1. The CE conformity marking (logo) shall consist of the initials “CE ” in the form shown below;
2. If the CE marking is reduced or enlarged the proportions given in the above-graduated drawing must be respected.
   – The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm;
3. The affixing of markings on the products which are likely to deceive third-parties as to the meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the products or the data plate provided that the visibility and legibility of the CE marking is not thereby reduced;

Attention:
It should be noted that the C and E are not formed by perfect semi-circles, i.e. the top and bottom arms extend one square beyond the semi-circles, and the middle arm of the E stops one square short.

EEA’s EC Rep symbol/logo download & Example of Use of Wellkang’s Name/Address
For European Authorised Representative/Authorized Representative service

• By appointing Wellkang as your European Authorised/Authorized Representative (EC Rep), you are allowed to print Wellkang’s name and address on your CE-marked Product, Labelling, Packaging, and Sales Literature of your CE-marked product in order to comply with the EU directives and relevant standard such as EN 980:2008.

You may use any or all of the following:

 

 

 

 

 

 

 

Definition:
The EC declaration of conformity is the written statement and the single declaration drawn up by the manufacturer to demonstrate the fulfillment of the EU requirements relating to a product bearing the CE marking he has manufactured. The declaration shall be in respect of all Community acts applicable to the product containing all information required for the identification of Community harmonization legislation to which the declaration relates.

This declaration must cover one or more products manufactured, clearly identified by means of product name, product code, or another unambiguous reference, and must be kept by the manufacturer, or his European Authorised Representative if the manufacturer is based outside the EU.

Required content (template)
for the CE marking EC Declaration of Conformity

The newest required (minimum) content for Declaration of Conformity (DoC) according to the EU Official Journal published in August 2008 are:

———————————————————–

EC DECLARATION OF CONFORMITY

1.
No xxxxxx (unique identification of the product):

2.
Name and address of the manufacturer and/or his authorized representative:

3.
This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):

4.
The object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):

5.
The object of the declaration described above is in conformity with the relevant Community harmonization legislation: ………

6.
References to the relevant harmonized standards used or references to the specifications in relation to which conformity is declared:

7.
Where applicable, the notified body … (name, number)… performed … (description of intervention) … and issued the certificate: ….

8.
Additional information:

Signed for and on behalf of: ………………………….

(place and date of issue)

(name, function) (signature)

———————————————————–

1. The manufacturer is any natural or legal person who is responsible for designing and manufacturing a product with a view to placing it on the Community market “under his own name” (or trademark*).
2. The responsibilities of the manufacturer apply also to any natural or legal person who assembles, packs, processes, or labels ready-made products with a view to their being placed on the Community market “under his own name”.
3. Further, the responsibility of the manufacturer is placed on any person who changes the intended use of a product in such a way that different essential requirements will become applicable, or substantially modifies or re-builds a product (thus creating a new product), with a view to placing it on the Community market.
4. The manufacturer may design and manufacture the product himself. As an alternative, he may have it designed, manufactured, assembled, packed, processed, or labeled with a view to placing it on the Community market “under his own name”, and thus presenting himself as a manufacturer. Where sub-contracting takes place, the manufacturer must retain the overall control for the product and ensure that he receives all the information that is necessary to fulfill his responsibilities according to the New Approach directives. The manufacturer who subcontracts some or all of his activities may in no circumstances discharge himself from his responsibilities, for example to an authorized representative, a distributor, a retailer, a wholesaler, a user, or a sub-contractor.
5. The manufacturer has sole and ultimate responsibility for the conformity of the product to the applicable directives, whether he designed and manufactured the product himself or is considered as a manufacturer because the product is placed on the market “under his name”.

* According to the Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008,
‘manufacturer’ shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product “under his name or trademark.”

Any economic operator that either places a product on the market under his own name or trademark or modifies a product in such a way that compliance with applicable requirements may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.

Own Brand Labeller
(also referred to as Private Labeller)
Own Brand Labeling 

• An Own Brand Labeller (OBL) purchases a finished (or component parts of a) medical device from the Original Equipment Manufacturer (OEM), which he then places on the market under his own name or trademark (brand label).
• This Own Brand Labeller may not be the person who actually designs, manufactures, packages or labels the device.

This economic operator, the Own Brand Labeller, meets the definition of the manufacturer as set out in the medical devices Directives. Own Brand Labeller or Private Labeller are therefore considered as the legal Manufacturer.

1. When placing their products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in the relevant part of the legislation.
2. Manufacturers shall draw up the required technical documentation and carry out the conformity assessment procedure applicable or have it carried out. Where compliance of a product with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC declaration of conformity and affix the conformity marking.
3. Manufacturers shall keep the technical documentation and the EC declaration of conformity for … [period to be specified in proportion to the lifecycle of the product and the level of risk] after the product has been placed on the market.
4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of a product is declared shall be adequately taken into account.When deemed appropriate with regard to the risks presented by a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of any such monitoring.
5. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.
6. Manufacturers shall indicate their name, registered trade name or registered trademark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted.
7. Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language that can be easily understood by consumers and other end-users, as determined by the Member State concerned.
8. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community harmonisation legislation shall immediately take the necessary corrective measures to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product, in a language that can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.

The European Union’s ‘New Approach directives are mandatory for all member countries to enact through national legislation.

This legislation requires manufacturers to display CE Marking on their product, packaging, and accompanying literature. Where a new approach directive is in force, it is (with few exceptions) an offense to place a product on the market without CE Marking. The manufacturer is legally responsible for ensuring that the product conforms to the requirements of the directive and for applying CE Marking.

CE Marking is one important measure that the EU has adopted to establish the single market and foster economic development for the member states. The objective of the directives is to simplify the movement of goods into and within the EU. This may eventually lead to the free movement of goods throughout Europe as more and more European countries are expected to join the EU. The European Commission thus refers to the CE Marking as a “Passport” which allows products to be freely circulated within the EU single market.

Often, consumers will consider CE Marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of safety that other products may lack. CE Marking is thus for many consumers a “Symbol of Safety.” Being a manufacturer exporting to the EU, if you have not got your products fixed with CE Marking, it is now time to invest in it. A CE Marking on your product will be more valuable than millions of dollars spent on TV advertising. Nowadays, it is not unusual to see some high-quality, even known brand, products have to appear in Second-hand Stores (which sells used products) or on street-vendor’s Stands. Why? lack CE Marking!

Does my product need CE Marking?
CE Marking is most probably required if you export to the 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states the following 20 groups of products –

1. Appliances Burning Gaseous Fuels (applicants)
   The “appliances burning gaseous fuels” used for cooking, heating, hot water production, refrigeration, lighting, or washing and having, where applicable, a normal water temperature not exceeding 105 GC. Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances.
   The “gaseous fuel” means any fuel which is in a gaseous state at a temperature of 15 GC under a pressure of 1 bar. 
2. Cableway Installations to Carry Persons
   The “cableway installations designed to carry persons” shall mean installations made up of several components, designed, manufactured, assembled, and put into service with the object of carrying persons.
   These on-site installations are used for the carriage of persons in vehicles or by towing devices, whereby the suspension and/or traction is provided by cables positioned along the line of travel. 

3. Low Voltage Electrical Equipment
   The “Electrical Equipment” means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.). Therefore, it is called often “Low Voltage Electrical Equipment” which includes the vast majority of electrical equipment in everyday use. 
4. Construction Products
   The “construction product” means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works. 
5. Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (Atex)
   • Equipment means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof, and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control, and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition.
   • Protective systems mean design units that are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems.
   • Components mean any item essential to the safe functioning of equipment and protective systems but with no autonomous function. Explosive atmospheres Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapors, mists, or specks of dust in which, after ignition has occurred, combustion spreads to the entire unburned mixture.

   A potentially explosive atmosphere means an atmosphere that could become explosive due to local and operational conditions. 

6. Explosives for Civil Uses
   The “Explosives” here shall mean the materials and articles considered to be such in the United Nations Recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations. 
7. Hot Water Boilers
   The “hot-water boilers” here means a boiler fired by liquid or gaseous fuels with a rated output of between 4 kW and 400 kW (including 4 kW and 400 kW). 
8. Lift
   The “lift” here means an appliance serving specific levels, having a car moving along guides that are rigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transport of:
   – persons,
   – persons and goods,
   – goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside. 
9. Machinery
   the “machinery” means:
10. an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control, and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of the material,
11. an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
12. • interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool. 
13. Measuring Instruments
    the “measuring instrument” means: any device or system with a measurement function that is covered by Articles 1 and 3; 
14. Medical Devices
    A “Medical Device” is defined in Directive (93/42/EEC) as any instrument, apparatus, appliance, material, or another article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
    
    • diagnosis, prevention, monitoring, treatment, or alleviation of a disease, an injury, or a handicap.
    • the investigation, replacement, or modification of the anatomy or of a physiological process.
    • control of conception

         and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted by such means. 

15. Active Implantable Medical Devices
    The “active medical device” means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity
    The “active implantable medical device” means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. 
16. In Vitro Diagnostic Medical Devices
    The “in vitro diagnostic medical device” means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
    – concerning a physiological or pathological state, or
    – concerning a congenital abnormality, or
    – to determine the safety and compatibility with potential recipients, or
    – to monitor therapeutic measures. 
17. Non-automatic Weighing Instruments
    A “Weighing Instrument” is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters, or characteristics.
    A “non-automatic weighing instrument” is defined as a weighing instrument requiring the intervention of an operator during weighing. 
18. Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
    A “radio equipment” means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilizing the spectrum allocated to terrestrial/space radiocommunication.A “telecommunications terminal equipment” means a product enabling communication or a relevant component thereof which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunications networks (that is to say, telecommunications networks used wholly or partly for the provision of publicly available telecommunications services).
19. Personal Protective Equipment (PPE)
    “personal protective equipment” means any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.
20. Simple Pressure Vessels
    The “simple pressure vessel” means any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired. 
21. Pressure Equipment
    The “Pressure Equipment” means vessels, piping, safety accessories, and pressure accessories.
    Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.
    ‘Vessel` means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment. A vessel may be composed of more than one chamber.
    ‘Piping` means piping components intended for the transport of fluids, when connected together for integration into a pressure system. Piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate. Heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping.
    ‘Safety accessories` means devices designed to protect pressure equipment against the allowable limits being exceeded. Such devices include:
    – devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and
    – limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockouts, such as pressure switches or temperature switches or fluid level switches and ‘safety-related measurement control and regulation (SRMCR)` devices.
    ‘Pressure accessories` means devices with an operational function and having pressure-bearing housings.
    ‘Assemblies` means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.
22. Recreational Craft
    The “Recreational craft” means any boat of any type, regardless of the means of propulsion, from 2,5 to 24 m hull length, measured according to the appropriate harmonized standards intended for sports and leisure purposes.
23. Toys
    A “toy” shall mean any product or material designed or clearly intended for use in play by children less than 14 years of age.

How to achieve CE mark approval, CE testing, and meet all CE mark requirements, for my product?

There are a series of steps outlined below for CE mark approval. Depending upon your product and the nature of the risks it presents:

1. Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
2. Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
3. Choose the conformity assessment procedure from the options (modules) called out by the directive for your product. There are several modules available for the Conformity Assessment Procedures as listed below:Module A: internal production control
   Module Aa: intervention of a Notified Body
   Module B: EC type-examination
   Module C: conformity to type
   Module D: production quality assurance
   Module E: product quality assurance
   Module F: product verification
   Module G: unit verification
   Module H: full quality assurance

The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called “Conformity Assessment Procedures”. The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.

Minimal Risk

Options for products with minimal risk include self-certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product.

Greater Risks

Many directives require products/systems with greater risks to be independently certified; this must be done by a “Notified Body”. This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be private sector organizations or government agencies. Manufacturers may choose a notified body in any member state of the European Union. Lists of notified bodies are published by the European Commission in the Official Journal of the European Communities.

A Notified Body is usually able to offer some of the services required:

• product testing
• type-examination certificate issue
• Technical File and design dossier evaluation
• surveillance of product and quality system
• identification of standards

 

1. If your products need to be certified by a Notified Body, then you will need to do as follows:

 

1. Select the applicable product standards and test methods for your product and select a Notified Body.
2. Establish an Authorized Representative in the European Union for your product.Some directives require that a manufacturer designates in the European Union and authorized representative to produce Technical Documentation (or sometimes called Technical File) in a timely fashion when called upon to do so. The CE Marking itself is not meant to provide details about the product to Surveillance Authorities.

    Technical Documentation (Technical File): The directives require for many products that a Technical Documentation (Technical File) be prepared by the manufacturer. The Technical Documentation (Technical File) holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.

3. Prepare a Declaration of Conformity.
   The Declaration of Conformity must contain information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union. It may include a list of the directives and standards that your product conforms to, product identification, the manufacturer’s name, address, and signature.
4. Register your product in the EU
   Many products, for instance, Class I Medical Devices, are required to be registered in the EU and, if proved, get a Certificate of Registration. Without this Certificate of Registration, the products are NOT allowed to be affixed with the CE Marking and be placed on the market.
5. Affix the CE Marking to your product.
   There are specific rules to adhere to for the CE Marking. These rules address the size and location of the Marking; affixing the CE Marking to products, packaging, and material or documents shipped with the product; and specific limitations on when and who is permitted to affix the CE Marking.

How can Wellkang help you?

Wellkang’s mission is to provide a comprehensive range of business services aimed at assuring European product conformity. The in-depth expertise of our professionals and extensive working experience in a wide industrial spectrum enables us to achieve this goal. Wellkang strives to establish a close, trusting relationship with our clients based on proven performance and total dedication to their products.

1. EU Documentation and Standards Delivery Service.
   

   • 1.1 EU Product Directives
   • 1.2 European Standards
   • 1.3 Other EU Official Documents

2. Technical Consulting Service
   

   • 2.1 Technical Advice on Compliance Engineering
   • 2.2 Safety and Risk Assessments

3. Compliance Testing Service
   

   • 3.1 Pre-compliance testing arrangement
   • 3.2 Full-compliance testing arrangement

4. Technical Documentation Service
   

   • 4.1 Technical Files (Technical Documentation):
     guiding you preparing this document.
   • 4.2 EC Declaration of Conformity:
     guiding you preparing this document, we have different models in several languages.

5. Labeling and Document Translation
   (We can arrange the translation from English into the official language(s) of every EU member state)

   • 5.1 Users Manual and Installation Instructions
   • 5.2 Labeling Advice and Translation

6. European (EEA/EU) Authorised/Authorized Representative Service
   

   • 6.1 Use of Wellkang’s Name & Address:By appointing Wellkang as your European Authorised/Authorized Representative, you are allowed to print Wellkang’s Name and Address on the packaging, labeling and sales literature of your CE-marked products in order to comply with the EU directives.
   • 6.2 Product Registration:
     As your European Authorised/Authorized Representative, we can register your MDD/IVD products in EEA with the Competent Authority (CA).
   • 6.3 Renewal and Update Product Registration:
     The product registration information must be updated regularly or whenever it changes. Wellkang will update your information with the Competent Authority (CA), where applicable.
   • 6.4 Keep Your Technical Files:
     As your European Authorised/Authorized Representative, we store and update the Technical Files of your products sold in Europe. The Technical Files may be inspected at any time by the Competent Authorities for a period ending at least five (5) years after the last product has been manufactured.
   • 6.5 Legislation Monitoring:
     We monitor and report on new developments in European product legislation relevant to your products.
   • 6.6 Vigilance and Incident Reporting:
     As your European Authorized/Authorised Representative, we assist with product vigilance and incident reporting.
   • 6.7 Product Recalls and Advisory Notices:
     As your European Authorized/Authorised Representative, we assist with Product Recalls and the issuing of Advisory Notices

EC Rep: what is a European (EEA/EU/EC, UK) Authorised Representative (Authorized Representative)?

An (EEA/EU/EC, UK) European Authorised Representative (also called Authorized Representative) is a natural or legal person established in the European Economic Area (EEA, including EU & EFTA) or United Kingdom (UK), who, explicitly designated by a non-European manufacturer, acts on his behalf in carrying out certain tasks required in the applicable directives.

• For the purposes of New Approach directives, the Authorised/Authorized Representative must be established inside the Community.
• The Authorised/Authorized Representative may be addressed by authorities and bodies in the EEA Member States instead of the manufacturer with regard to the latter’s obligations under the New Approach Directives.
• Commercial representatives of the manufacturer (such as importer, authorized/authorized agent, authorized/authorized distributor), whether or not established inside the Community, are not to be confused with the Authorised/Authorized Representative in the meaning of New Approach directives.
• The manufacturer remains generally responsible for actions carried out by an Authorised/Authorized Representative on his behalf.

The delegation of tasks from the manufacturer to the Authorised/Authorized Representative must be explicit and should take place in writing, in particular, to define the contents of the tasks and the limits of the representative’s powers. The tasks that may be delegated to the Authorised/Authorized Representative according to the directives are of an administrative nature. Thus, the manufacturer may neither delegate the measures necessary to ensure that the manufacturing process assures compliance of the products nor the setting up of technical documentation unless otherwise provided for. Further, an EEA/EU/EC Authorised/Authorized Representative cannot modify the product on his own initiative in order to bring it into line with the applicable directives.

*Article 14.2

•  of Council Directive 93/42/EEC as amended by Directive 2007/47/EC:

 

• Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a

single authorized representative

in the European Economic Area (EEA)

. For devices referred to in the first subparagraph of paragraph 1, the authorized representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.

UK Rep: what is a UK Responsible Person (commonly known as UK Authorised Representative (Authorized Representative))?

A UK Authorised Representative (Authorized Representative) (officially so-called “UK Responsible Person”) means a person (natural or legal person) established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the (non-UK) manufacturer’s obligations under UK regulations.

The European Economic Area (EEA):

The EEA includes EU countries and also Iceland, Liechtenstein, and Norway. It allows them to be part of the EEA single market.

Switzerland is neither an EU nor EEA member but is part of the single market.

For the purposes of CE Marking conformity and single market or UK market, references to EU countries should be read as references also to EEA states (incl. Iceland, Liechtenstein, and Norway).

Directive or Guideline	Products or Title	Mandatory from
Type A: Basic Directives ( for all products)
85/374/EEC	Liability for Defective Products	30 Jul 1988
1999/34/EC	Liability for Defective Products (amending)	10 May 1999
92/59/EEC	General Products Safety	1 Jan 1997
2001/95/EC	(new) General Products Safety Directive	1 Jan 2003
93/68/EEC	“CE Marking” Directive	22 Jul 1993
93/465/EEC	Conformity Assessment Procedures & CE Marking Rules	22 Jul 1993
Guideline	Guide to Implementation of directives based on new approach & global approach	Pub. 2000
Type B: Generic Directives (take precedence over Type A)
73/23/EEC	Low Voltage Electrical Equipment (LVD)	1 Jan 1997
Framework	2000&2001 Framework of implementation of LVD 73/23/eec (79pages)	Pub. 2001
Guideline	Guideline on Low Voltage Directive (LVD) 73/23/EEC & Annex I, II	Pub. Jul 1997
89/336/EEC	Electromagnetic Compatibility (EMC)	1 Jan 1996
Guideline	Guideline on Directive of Electromagnetic Compatibility (EMC) 89/336/eec	Pub. 2001
Tech-Aspects	Technical-Aspects relating Electromagnetic Compatibility EMC 89/336/eec (150pages)	Pub. 2001
Framework	the framework of the implementation of EMC Directive 89/336/EEC	Pub. 2000
2002/95/EC	RoHS- Restriction of use of Hazardous Substances in Electrical and Electronic Equipment	–
2002/96/EC	WEEE- Waste from Electrical and Electronic Equipment	–
Type C: Product-Specific Directives (take precedence over Type A & B)
87/404/EEC	Simple Pressure Vessels	1 Jul 1992
88/378/EEC	Toys	1 Jan 1990
Guideline	Guidance to 88/378/eec Toys (for Scooter & FloatingSeats)	Pub. 2001
89/106/EEC	Construction Products	27 Jun 1991
Guideline	Guidance to Directive 89/106/eec: Construction Products	Pub. 2001
89/686/EEC	Personal Protective Equipment (PPE)	1 Jul 1995
UsefulFacts	Useful Facts relating to Directive 89/686/eec PPE (143pages)	Pub. 2001
Framework	The framework of the implementation of (PPE) Directive 89/686/eec (13pages)	Pub. 2001
90/384/EEC	Non-automatic Weighing Instruments	1 Jan 2003
90/396/EEC	Appliances Burning Gaseous Fuels (AppliGas)	1 Jan 1996
Framework	The framework of the implementation of (AppliGas) Directive 90/396/eec	Pub. 2001
92/42/EEC	The efficiency of (Liquid or Gaseous fueled) Hot Water Boilers	1 Jan 1998
93/15/EEC	Explosives for Civil Uses	1 Jan 2003
93/42/EEC	Medical Devices	14 Jun 1998
Guidelines	Guidelines for Classification of Medical Devices	Pub. 2001
Guideline	Guideline relating to the demarcation between Directives 90/385/eec, 93/42/eec, and 65/65/eec.	Pub. 1998
90/385/EEC	Active Implantable Medical Devices	1 Jan 1995
98/79/EC	In Vitro Diagnostic Medical Devices	7 Dec 2003
Guideline	Guideline on Medical Devices Vigilance System	Pub. 1998
93/65/EEC	Air Traffic Management Equipment & Systems	19 Jul 1994
94/9/EC	Equipment used in Potentially Explosive Atmospheres (Atex)	1 Jul 2003
Framework	The framework of the implementation of (Atex) Directive 94/9/ec, 7pages	Pub. 2001
Guideline	Guideline on directive 94/9/ec (Atex)	Pub. 2000
94/25/EC	Recreational Craft	16 Jun 1998
Guid&Frame	Guidelines&Framework: directive 94/25/EC (RecCraft) (106pages)	Pub. 2001
95/16/EC	Lifts	30 Jun 1999
96/48/EC	Trans-European High-speed Rail System	8 Oct 1996
96/57/EC	Energy Efficiency: Household Refrigerators & Freezers	3 Sep 1999
96/98/EC	Marine Equipment	1 Jan 1999
97/23/EC	Pressure Equipment	29 May 2002
Framework	2000&2001 Framework of implementation of Directive 97/23/EC	Pub. 2001
1998/37/EC	Machinery	1 Jan 1995
Comments	Comments on Directive of Machinery 98/37/EC (269pages)	Pub. 2000
UsefulFacts	Useful Facts relating to Directive of Machinery 98/37/EC (266pages)	Pub. 2001
Proposal	2001 Proposal to amend Directive 98/37/EC Machinery (106pages)	Pub. 2001
2000/14/EC	Noise Emission in the environment by equipment for use outdoors (78pages)	3 Jul 2000 (entry into force)
1999/5/EC	Radio Equipment & Telecommunications Terminal Equipment (R&TTE)	variable
Guidelines	Guidance to Directive 99/5/ec R&TTE, 38pages	Pub. 2001
Framework	2001 Framework of implementation of 99/5/ec R&TTE	Pub. 2001
1999/36/EC	Transportable Pressure Equipment Directive	–
2000/9/EC	Cableway Installations to Carry Persons	–
AGREEMENTs on mutual recognition of conformity assessment between European Union and Other countries
Agreement	Agreement between EU and United States (173pages)	Pub. 1999
Agreement	Agreement between EU and United States, amendation (24pages)	Pub. 2000
Agreement	Agreement between EU and Canada (137pages)	Pub. 1998
Agreement	Agreement between EU and Australia	Pub. 1998
Agreement	Agreement between EU and New Zealand	Pub. 1998
Agreement	Agreement between EU and Israel	Pub. 1999
Agreement	Agreement between EU and Japan 2001 proposal	Pub. 2001

 

 

Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations, and administrative provisions of the Member States concerning liability for defective products

 

Amendments: Amended by Council Directive 1999/34/EC of 10 May 1999 (OJ L 141 04.06.1999 p.20)THE COUNCIL OF THE EUROPEAN COMMUNITIES, … Whereas approximation of the laws of the Member States concerning the liability of the producer for damage caused by the defectiveness of his products is necessary because the existing divergences may distort competition and affect the movement of goods within the common market and entail a differing degree of protection of the consumer against damage caused by a defective product to his health or property; Whereas liability without fault on the part of the producer is the sole means of adequately solving the problem, peculiar to our age of increasing technicality, of a fair apportionment of the risks inherent in modern technological production;

…. Whereas the protection of the consumer requires that all producers involved in the production process should be made liable, in so far as their finished product, component part or any raw material supplied by them was defective; whereas, for the same reason, liability should extend to importers of products into the Community and to persons who present themselves as producers by affixing their name, trademark or other distinguishing feature or who supply a product the producer of which cannot be identified;
Whereas, in situations where several persons are liable for the same damage, the protection of the consumer requires that the injured person should be able to claim full compensation for the damage from any one of them; …
Whereas the protection of the consumer requires compensation for death and personal injury as well as compensation for damage to property; whereas the latter should nevertheless be limited to goods for private use or consumption and be subject to a deduction of a lower threshold of a fixed amount in order to avoid litigation in an excessive number of cases; whereas this Directive should not prejudice compensation for pain and suffering and other non-material damages payable, where appropriate, under the law applicable to the case; …
Whereas taking into account the legal traditions in most of the Member States, it is inappropriate to set any financial ceiling on the producer’s liability without fault; whereas, in so far as there are, however, differing traditions, it seems possible to admit that a Member State may derogate from the principle of unlimited liability by providing a limit for the total liability of the producer for damage resulting from a death or personal injury and cause by identical items with the same defect, provided that this limit is established at a level sufficiently high to guarantee adequate protection of the consumer and the correct functioning of the common market; …
HAS ADOPTED THIS DIRECTIVE:

Article 1
The producer shall be liable for damage caused by a defect in his product.

Article 2
For the purpose of this Directive ‘product’ means all movables, with the exception of primary agricultural products and games, even though incorporated into another movable or into an immovable. ‘Primary agricultural products’ means the products of the soil, of stock-farming, and of fisheries, excluding products which have undergone initial processing. ‘Product’ includes electricity.

Article 3
1. ‘Producer’ means the manufacturer of a finished product, the producer of any raw material or the manufacturer of a component part, and any person who, by putting his name, trademark, or other distinguishing feature on the product presents himself as to its producer.
2. Without prejudice to the liability of the producer, any person who imports into the Community a product for sale, hire, leasing or any form of distribution in the course of his business shall be deemed to be a producer within the meaning of this Directive and shall be responsible as a producer.
3. Where the producer of the product cannot be identified, each supplier of the product shall be treated as its producer unless he informs the injured person, within a reasonable time, of the identity of the producer or of the person who supplied him with the product. The same shall apply, in the case of an imported product, if this product does not indicate the identity of the importer referred to in paragraph 2, even if the name of the producer is indicated.

Article 4
The injured person shall be required to prove the damage, the defect, and the causal relationship between defect and damage.

Article 5
Where, as a result of the provisions of this Directive, two or more persons are liable for the same damage, they shall be liable jointly and severally, without prejudice to the provisions of national law concerning the rights of contribution or recourse.

Article 6
1. A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including:
(a) the presentation of the product;
(b) the use to which it could reasonably be expected that the product would be put;
(c) the time when the product was put into circulation.
2. A product shall not be considered defective for the sole reason that a better product is subsequently put into circulation.

Article 7
The producer shall not be liable as a result of this Directive if he proves:
Article 8

Article 9
For the purpose of Article 1, ‘damage’ means:
(a) damage caused by death or by personal injuries;
(b) damage to, or destruction of, any item of property other than the defective product itself, with a lower threshold of 500 ECU, provided that the item of property:
(i) is of a type ordinarily intended for private use or consumption, and
(ii) was used by the injured person mainly for his own private use or consumption.
This Article shall be without prejudice to national provisions relating to non-material damage.

Article 10

Article 11

Article 12
The liability of the producer arising from this Directive may not, in relation to the injured person, be limited or excluded by a provision limiting his liability or exempting him from liability.

Article 13
This Directive shall not affect any rights which an injured person may have according to the rules of the law of contractual or non-contractual liability or a special liability system existing at the moment when this Directive is notified.

Article 14

Article 15

Article 16
1. Any Member State may provide that a producer’s total liability for damage resulting from a death or personal injury and caused by identical items with the same defect shall be limited to an amount which may not be less than 70 million ECU (now, Euro).
2.

Article 17

Article 18

Article 19

Article 20

Article 21

Article 22

Article 1

Directive 1999/34/EC of the European Parliament and of the Council of 10 May 1999 amending Council Directive 85/374/EEC on the approximation of the laws, regulations, and administrative provisions of the Member States concerning liability for defective products.

 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community and in particular Article 95 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the Economic and Social Committee(2), Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), (1) Whereas product safety and compensation for damage caused by defective products are social imperatives which must be met within the internal market; whereas the Community has responded to those requirements by means of Directive 85/374/EEC(4) and Council Directive 92/59/EEC of 29 June 1992 on general product safety(5);

(2) Whereas Directive 85/374/EEC established a fair apportionment of the risks inherent in a modern society in which there is a high degree of technicality; whereas that Directive, therefore, struck a reasonable balance between the interests involved, in particular the protection of consumer health, encouraging innovation and scientific and technological development, guaranteeing undistorted competition and facilitating trade under a harmonized system of civil liability; whereas that Directive has thus helped to raise awareness among traders of the issue of product safety and the importance accorded to it;
(3) Whereas the degree of harmonization of Member States’ laws achieved by Directive 85/374/EEC is not complete in view of the derogations provided for, in particular with regard to its scope, from which unprocessed agricultural products are excluded;
(4) Whereas the Commission monitors the implementation and effects of Directive 85/374/EEC and in particular its aspects relating to consumer protection and the functioning of the internal market, which have already been the subject of a first report; whereas, in this context, the Commission is required by Article 21 of that Directive to submit a second report on its application;
(5) Whereas including primary agricultural products within the scope of Directive 85/374/EEC would help restore consumer confidence in the safety of agricultural products; whereas such a measure would meet the requirements of a high level of consumer protection;
(6) Whereas circumstances call for Directive 85/374/EEC to be amended in order to facilitate, for the benefit of consumers, legitimate compensation for damage to health caused by defective agricultural products;
(7) Whereas this Directive has an impact on the functioning of the internal market in so far as trade in agricultural products will no longer be affected by differences between rules on producer liability;
(8) Whereas the principle of liability without fault laid down in Directive 85/374/EEC must be extended to all types of product, including agricultural products as defined by the second sentence of Article 32 of the Treaty and those listed in Annex II to the said Treaty;
(9) Whereas, in accordance with the principle of proportionality, it is necessary and appropriate in order to achieve the fundamental objectives of increased protection for all consumers and the proper functioning of the internal market to include agricultural products within the scope of Directive 85/374/EEC; whereas this Directive is limited to what is necessary to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty,
HAVE ADOPTED THIS DIRECTIVE:

 

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on general product safety (presented by the Commission)EXPLANATORY MEMORANDUM 1. Introduction 2. Reasons, objectives, and main elements of the proposal 3. Subsidiarity 4. Economic aspects and impact on SMEs 5. Consultations 6. Contents of the proposal

THE PROPOSAL
1. Taking into account the principle of subsidiarity, why is Community legislation necessary in this area, and what are its main aims-
The General Product Safety Directive was adopted in 1992 as part of the program aimed at establishing by 31 December 1992, the internal market. The aims and motivations of the General Product Safety Directive, which remain unchanged, fall within the fundamental competencies of the European Community.
All the amendments proposed in the revised text are aimed at reinforcing the effectiveness of the Directive and ensuring a more consistent implementation of its provisions.
The absence of efficient market surveillance in one Member State can have negative consequences at the European level for the functioning of the Internal Market, for business competitiveness, and for consumer protection. The experience has shown certain weaknesses and lacunae in Community product safety legislation and its enforcement. This situation calls for improved Community provisions aimed at guaranteeing the protection of consumers and the proper functioning of the market.
The modifications envisaged are compatible with the need to respect the prerogative of Member States in deciding their own internal institutional and administrative arrangements and business regimes.

THE IMPACT ON BUSINESS
2. Who will be affected by the proposal-
The proposal will not significantly modify the implications for business compared with the present Directive. All business sectors and all sizes of businesses related to the production, distribution, and trade of consumer products are interested. The proposed Directive will also apply to business which uses or supply products in the provision of services to consumers.
The proposal has a similar impact on the entire Community. It is not aimed at any particular region.
3. What will the business have to do to comply with the proposal-
The main new additional obligations for business will be:
Obligations for producers:
to effectively warn consumers of the risks posed by those products already supplied to them, and when necessary and as a last resort recall such products in order to avoid such risks.
Obligations for distributors:
to collaborate in tracing of the products they supply and to co-operate in any risk avoidance action;
Obligations for producers and distributors:
to inform the competent authorities if they conclude that a product which they supply is dangerous. Specific information requirements are provided in Annex I.
to collaborate, in accordance with the requests of competent authorities, in taking action to avoid any risks posed by the products they supply.
not to export to non-Member States dangerous products subject to a Community decision prohibiting them from being placed on the Community market or which have been withdrawn from the market or recalled from the consumers.
However, it should be noted that the increased costs associated with the new obligations for SMEs will solely occur when a product is found not to comply with the safety requirements of the Directive.
4. What economic effects are the proposal likely to have-
This proposal will facilitate an effective and consistent framework for ensuring the protection of consumer health and safety, and equal treatment of producers, importers, and distributors.
Certain provisions of the proposal will improve businesses’ competitiveness. At present businesses which do not respect their obligations to protect consumer health and safety, have an unfair advantage over those that do. More effective market surveillance will reduce such unfair competition between businesses within the internal market and also in the context of the globalization of World trade. Businesses could also gain a marketing advantage in terms of the increased safety that their product offers.
The new “status” that the proposal will give to European standards, will help provide clear reference points for business in defining a safe product. This, in turn, will assist businesses and particularly SMEs in penetrating the internal market as the manufacturing and technical standards that need to be attained will cover a wider range of products. Common assessment criteria and product safety standards will permit businesses to compete on a level playing field by ensuring them equal opportunities.

1. introduction

2. reasons, objectives, and main elements of the proposal 3. subsidiarity

4. economic aspects and impact on small and medium-sized enterprises
Several of the new or modified provisions introduced by the proposed revision are of an administrative nature (such as those concerning the reinforcement of market surveillance, better collaboration between the Member States, improvement to the RAPEX system, etc.) and have no impact on economic operators.
Certain other amendments only aim at clarifying the present text to ensure more effective and consistent implementation (for instance the amendments concerning the scope of the Directive, its relationships with other Directives, etc.). Also, in this case, there is no impact of the amendments on economic operators.
However, a few proposed amendments may well have economic implications for businesses:
– the obligation of producers and distributors to inform the authorities when they conclude that a product that they supply is dangerous;
– the obligation of producers and distributors to collaborate with the authorities in order to prevent risks to consumer health and safety;
– the obligation to recall dangerous products, when necessary in order to prevent risks;
– the prohibition on the export to non-EU countries of dangerous products.
All these obligations, except the last one, apply only in the case where economic operators have placed on the market a dangerous product, in breach of the fundamental obligation to market only safe products. Producers and distributors can therefore prevent or at least minimize the economic consequences of these obligations by carefully assessing the risks of their products before their placing on the market, which is an obligation under the present Directive.
It is not possible to estimate how frequently there will be a need to apply these obligations: all will depend on the care taken by the relevant economic operators to supply only safe products. Equally, the economic implications of each of the provisions considered will depend on the nature and circumstances of non-compliance and therefore no meaningful estimate can be carried out beforehand.
The obligation of producers and distributors to inform the authorities when they conclude that a product that they supply is dangerous is already applied in certain non-EU countries, in particular the US. It is equally applied to European firms operating on the markets of these non-EU countries and there is no evidence of an excessive burden.
The costs associated with the obligation to collaborate with the authorities, in particular in the case of crises, like those recently experienced in the food sector, should be seen in the context of the broader economic consequences that failure to deal rapidly and effectively with consumer risks in such cases may have. Clearly, each of these cases involves specific aspects and no a priori quantification of costs and benefits is possible.
The same applies to the recall of products already supplied to consumers. The cost of a recall will vary, depending on factors such as geographical spread, number of products sold, the value of the products, etc. The benefits of timely recalls in economic terms will include reduced liabilities for the producers.
Finally, there is no data on the type and number of dangerous products exported, or which might in the future be exported to non-EU countries. The potential market lost by European producers, and the benefits deriving from the proposed prohibition of such exports, cannot be evaluated.
It should be borne in mind that any increased costs associated with the new obligations for SMEs will solely occur when a product is found not to comply with the safety requirements of the Directive. Therefore, the vast majority of businesses will only experience the following benefits as a result of the revision of the Directive.
First, businesses that do not respect their obligations to protect consumer health and safety may have an unfair advantage over those that do, if enforcement is not effective. More effective market surveillance will reduce such unfair competition between businesses within the internal market and also in the context of the globalization of trade.
Secondly, increased collaboration with market surveillance authorities could help small and medium-sized firms. Where an unsafe product is supplied by SMEs, national authorities should cooperate closely with them to ensure that appropriate actions or measures are taken to deal with the problem.
Finally, the proposal also aims to clarify the safety requirements applicable to products. The new “status” that the proposal will give to European standards, coupled with the possible use of Commission recommendations setting guidelines on risk assessment, will help provide clear reference points for business in defining a safe product. This will assist businesses and particularly SMEs in placing products in the internal market.
Common assessment criteria and product safety standards will permit businesses to compete on a level playing field by ensuring them equal opportunities. Increased use of European standards should be linked to the reinforcement of market surveillance.

5. consultations
The organizations consulted about the proposal and who have outlined their main views are:

6. contents of the proposal
This proposal concerns an EEA matter and should therefore extend to the EEA.
The amendments proposed with reference to the existing text are identified by underlining.
Article 1
Article 2
Article 3 obliges producers to market only safe products. It provides criteria for assessing the conformity of a product with the general safety requirement and allows products in compliance with European standards established under certain conditions, to benefit from a presumption of conformity.
Article 4
Article 5
Article 6
Article 7 establishes the obligation for the Member States to lay down rules on penalties.
Article 8
Article 9
Articles 10
Article 11
Article 12 provides for a rapid exchange of information system among the Member States and the Commission concerning products that present a serious risk which requires rapid intervention and measures taken by producers, distributors, and public authorities to deal with it. Participation in this system may be open to non-EU countries.
Article 13
Article 14
Article 15
Article 16
Article 17 clarifies that the application of this Directive shall be without prejudice to Directive 85/374/EEC concerning liability for defective products.
Article 18
Article 19
Article 20
Article 21
Directive 92/59/EEC is hereby repealed with effect from 1 January 2003 without prejudice to the obligations of Member States concerning the deadlines for transposition and for application of the repealed Directive as indicated in Annex III.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV.
Article 22

ANNEX I
REQUIREMENTS CONCERNING INFORMATION ON DANGEROUS PRODUCTS TO BE PROVIDED TO COMPETENT AUTHORITIES BY PRODUCERS AND DISTRIBUTORS

ANNEX II
PROCEDURES FOR THE APPLICATION OF THE COMMUNITY RAPID INFORMATION SYSTEM (RAPEX) PROVIDED FOR IN ARTICLE 13 AND GUIDELINES FOR NOTIFICATIONS REFERRED TO IN ARTICLES 12 AND 13

ANNEX III
REPEALED DIRECTIVE AND DEADLINES FOR TRANSPOSITION INTO NATIONAL LAW AND FOR APPLICATION

COUNCIL DIRECTIVE 92/59/EEC of 29 June 1992 It is necessary to establish on a Community level a general safety requirement for any product placed on the market that is intended for consumers or likely to be used by consumers; whereas certain second-hand goods should nevertheless be excluded by their nature; Production equipment, capital goods, and other products used exclusively in the context of a trade or business are not covered by this Directive; Article 1 1. The purpose of the provisions of this Directive is to ensure that products placed on the market are safe.

2. The provisions of this Directive shall apply in so far as there are no specific provisions in rules of Community law governing the safety of the products concerned.

Article 2

1. product
   shall mean any product intended for consumers or likely to be used by consumers, supplied whether for consideration or not in the course of commercial activity and whether new, used, or reconditioned.
   However, this Directive shall not apply to second-hand products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that the supplier clearly informs the person to whom he supplies the product to that effect;
2. safe product
   shall mean any product which, under normal or reasonably foreseeable conditions of use, including duration, does not present any risk or only the minimum risks compatible with the product’s use, considered as acceptable and consistent with a high level of protection for the safety and health of persons, taking into account the following points in particular:
   • – the characteristics of the product, including its composition, packaging, instructions for assembly and maintenance,
   • – the effect on other products, where it is reasonably foreseeable that it will be used with other products,
   • – the presentation of the product, the labeling, any instructions for its use and disposal, and any other indication or information provided by the producer,
   • – the categories of consumers at serious risk when using the product, in particular children.

   The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be ‘unsafe’ or ‘dangerous’;

3. dangerous product
   shall mean any product which does not meet the definition of ‘safe product’ according to point (b) hereof;
4. producer shall mean:
   1. – the manufacturer of the product, when he is established in the Community, and any other person presenting himself as the manufacturer by affixing to the product his name, trademark or another distinctive mark, or the person who reconditions the product,
   2. – the manufacturer’s representative, when the manufacturer is not established in the Community or if there is no representative established in the Community, the importer of the product,
   3. – other professionals in the supply chain, insofar as their activities may affect the safety properties of a product placed on the market.
5. distributor
   shall mean any professional in the supply chain whose activity does not affect the safety properties of a product.

Article 3

General safety requirement 

1. Producers shall be obliged to place only safe products on the market.
2. Within the limits of their respective activities, producers shall:
   2.1 – provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks.Provision of such warnings does not, however, exempt any person from compliance with the other requirements laid down in this Directive,
   2.2 – adopt measures commensurate with the characteristics of the products which they supply, to enable them to be informed of risks which these products might present and to take appropriate action including, if necessary, withdrawing the product in question from the market to avoid these risks.The above measures shall for example include, whenever appropriate, marking of the products or product batches in such a way that they can be identified, sample testing of marketed products, investigating complaints made, and keeping distributors informed of such monitoring.
3. Distributors shall be required to act with due care in order to help to ensure compliance with the general safety requirement, in particular by not supplying products which they know or should have presumed, on the basis of the information in their possession and as professionals, do not comply with this requirement. In particular, within the limits of their respective activities, they shall participate in monitoring the safety of products placed on the market, especially by passing on information on product risks and cooperating in the action taken to avoid these risks.

Article 4

1. Where there are no specific Community provisions governing the safety of the products in question, a product shall be deemed safe when it conforms to the specific rules of national law of the Member State in whose territory the product is in circulation.

2. In the absence of specific rules as referred to in paragraph 1, the conformity of a product to the general safety requirement shall be assessed having regard to voluntary national standards giving effect to a European standard or, where they exist, to Community technical specifications or, failing these, to standards drawn up in the Member State in which the product is in circulation, or to the codes of good practice in respect of health and safety in the sector concerned or to the state of the art and technology and to the safety which consumers may reasonably expect.

3. Conformity of a product with the provisions mentioned in paragraphs 1 or 2 shall not bar the competent authorities of the Member States from taking appropriate measures to impose restrictions on its being placed on the market or to require its withdrawal from the market where there is evidence that, despite such conformity, it is dangerous to the health and safety of consumers.

Obligations and powers of the Member States

Article 5

The Member States shall adopt the necessary laws, regulations, and administrative provisions to make producers and distributors comply with their obligations under this Directive in such a way that products placed on the market are safe.

In particular, Member States shall establish or nominate authorities to monitor the compliance of products with the obligation to place only safe products on the market and arrange for such authorities to have the necessary powers to take the appropriate measures.
(a) organizing appropriate checks on the safety properties of products, even after their being placed on the market as being safe, on an adequate scale, up to the final stage of use or consumption;
(b) requiring all necessary information from the parties concerned;
(c) taking samples of a product or a product line and subjecting them to safety checks;
(d) subjecting product marketing to prior conditions designed to ensure product safety and requiring that suitable warnings be affixed regarding the risks which the product may present;
(e) making arrangements to ensure that persons who might be exposed to risk from a product are informed in good time and in a suitable manner of the said risk by, inter alia, the publication of special warnings;
(f) temporarily prohibiting, for the period required to carry out the various checks, anyone from supplying, offering to supply or exhibiting a product or product batch, whenever there are precise and consistent indications that they are dangerous;
(g) prohibiting the placing on the market of a product or product batch which has proved dangerous and establishing the accompanying measures needed to ensure that the ban is complied with;
(h) organizing the effective and immediate withdrawal of a dangerous product or product batch already on the market and, if necessary, its destruction under appropriate conditions.

2. The measures to be taken by the competent authorities of the Member States under this Article shall be addressed, as appropriate, to:
(a) the producer;
(b) within the limits of their respective activities, distributors and in particular the party responsible for the first stage of distribution on the national market;
(c) any other person, where necessary, with regard to cooperation in action taken to avoid risks arising from a product.

COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993
THE COUNCIL OF THE EUROPEAN COMMUNITIES, has adopted this directive:

Article 1

The following Council Directives are hereby amended:

 

1. 87/404/EEC of 25 June 1987 (simple pressure vessels) (7); 2. 88/378/EEC of 3 May 1988 (safety of toys) (8); 3. 89/106/EEC of 21 December 1988 (construction products) (9); 4. 89/336/EEC of 3 May 1989 (electromagnetic compatibility) (10); 5. 89/392/EEC of 14 June 1989 (machinery) (11); 6. 89/686/EEC of 21 December 1989 (personal protective equipment) (12); 7. 90/384/EEC of 20 June 1990 (non-automatic weighing instruments) (13); 8. 90/385/EEC of 20 June 1990 (active implantable medical devices) (14); 9. 90/396/EEC of 29 June 1990 (appliances burning gaseous fuels) (15); 10. 91/263/EEC of 29 April 1991 (telecommunications terminal equipment, including the mutual recognition of their conformity) (16); 11. 92/42/EEC of 21 May 1992 (efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels) (17); 12. 73/23/EEC of 19 February 1973 (electrical equipment designed for use within certain voltage limits) (18).

 

From Article 2 to Article 13

Detailed amendments were given, throughout from Article 2 to Article 13, to the 12 Council Directives listed in Article 1. Amendments varied from Directive to Directive. But, in general, the following basic points were included in the amendments to almost every Directive:

1. Throughout the text, the term EC mark was replaced by CE marking;
2. Member States shall presume that products bearing the CE marking comply with all the provisions of this Directive, including the conformity assessment procedures;
3. (a) Where the products are subject to other Directives covering other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the products in question are also presumed to conform to the provisions of those other Directives.
   (b) However, where one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity only to the Directives applied by the manufacturer. In this case, particulars of the Directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the Directives and accompanying such products;
4. EC verification
   4.1 EC verification is the procedure whereby a manufacturer or his authorized representative established within the Community ensures and declares that the products are in conformity to the type described in the EC type-examination certificate or with the design and manufacturing schedule referred to in Annex II section 3 having received a certificate of adequacy;
   4.2 The manufacturer shall take all the necessary measures for the manufacturing process to ensure that the products conform to the type described in the EC type-examination certificate or to the design and manufacturing schedule referred to in Annex II section 3. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each product and draw up a declaration of conformity;
   4.3 The approved body shall carry out the appropriate examinations and tests in order to check the conformity of the products with the requirements of this Directive by examination and testing of products;
   4.4 The manufacturer or his authorized representative must be able to supply on request the approved body’s certificates of conformity;
5. (a) where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorized representative established within the Community shall be obliged to make the product conform as regards the provisions concerning the CE marking and to end the infringement under the conditions imposed by the Member State;
   (b) where non-conformity continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market ;
6. The CE conformity marking shall consist of the initials “CE ” in the form shown below;
   
7. If the CE marking is reduced or enlarged the proportions given in the above-graduated drawing must be respected.
   – The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm;
8. The affixing of markings on the products which are likely to deceive third-parties as to the meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the products or the data plate provided that the visibility and legibility of the CE marking is not thereby reduced;
9. EC declaration of conformity
   The EC declaration of conformity must contain certain elements;
10. The manufacturer must establish the technical documentation and he or his authorized representative established within the Community must keep it on Community territory at the disposal of the relevant national authorities for inspection purposes for a certain period after the last product has been manufactured;
    Where neither the manufacturer nor his authorized representative is established within the Community, this obligation is the responsibility of the person who places the products on the Community market, e.g. the importer;
11. The technical documentation must enable the conformity of the product to the requirements of this Directive to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture, and operation of the product. It must include certain information;

Article 14

1. Member States shall adopt and publish the laws, regulations, and administrative provisions necessary to comply with this Directive by 1 July 1994.
They shall apply these provisions from 1 January 1995.
2. Until 1 January 1997 Member States shall allow the placing on the market and the bringing into service of products which comply with the marking arrangements in force before 1 January 1995.

COUNCIL DECISION 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives.

Article 11. The procedures for conformity assessment which are to be used in the technical harmonization directives relating to the marketing of industrial products will be chosen from among the modules listed in the Annex and in accordance with the criteria set out in this Decision and in the general guidelines in the Annex. These procedures may only depart from the modules when the specific circumstances of a particular sector or directive so warrant. Such departures from the modules must be limited in extent and must be explicitly justified in the relevant directive. 2. This Decision lays down rules for affixing the CE conformity marking provided for in Community legislation concerning the design, manufacture, placing on the market, entry into service, or use of industrial products. 3. The Commission shall report periodically on the functioning of this Decision, and on whether conformity assessment and CE marking procedures are working satisfactorily or need to be modified.

Article 2
1. Decision 90/683/EEC is hereby repealed.
2. References to the Decision repealed shall be construed as references to this Decision.

ANNEX
CONFORMITY ASSESSMENT PROCEDURES AND CE MARKING IN THE TECHNICAL HARMONIZATION DIRECTIVES

I. GENERAL GUIDELINES
A. The principal guidelines for the use of conformity assessment procedures in technical harmonization directives are the following:
(a) the essential objective of a conformity assessment procedure is to enable the public authorities to ensure that products placed on the market conform to the requirements as expressed in the provisions of the directives, in particular with regard to the health and safety of users and consumers;
(b) conformity assessment can be subdivided into modules that relate to the design phase of products and to their production phase;
(c) as a general rule a product should be subject to both phases before being able to be placed on the market if the results are positive (1) ;
(d) there are a variety of modules that cover the two phases in a variety of ways. The directives must set the range of possible choices which can be considered by the Council to give the public authorities the high level of safety they seek, for a given product or product sector;
(e) in setting the range of possible choices open to the manufacturer, the directives, will take into consideration, in particular, such issues as the appropriateness of the modules to the type of products, the nature of the risks involved, the economic infrastructures of the given sector (e.g. existence or non-existence of third parties), the types and importance of production, etc. The factors that have been taken into account must be explicitly spelled out by the Commission in these directives;
(f) the directives will, in setting the range of possible modules for a given product or product sector, attempt to leave as wide a choice to the manufacturer as is consistent with ensuring compliance with the requirements.
The directives will set out the criteria governing the conditions in which the manufacturer chooses the most appropriate modules for his production from the modules laid down by the directives;
(g) the directives should avoid imposing unnecessarily modules that would be too onerous relative to the objectives of the directive concerned;
(h) notified bodies should be encouraged to apply the modules without unnecessary burden for the economic operators. The Commission, in cooperation with the Member States, must ensure that close cooperation is organized between the notified bodies in order to ensure consistent technical application of the modules;
(i) in order to protect the manufacturers, the technical documentation provided to notified bodies has to be limited to that which is required solely for the purpose of assessment of conformity. Legal protection of confidential information is required;
(j) whenever directives provide the manufacturer with the possibility of using modules based on quality assurance techniques, the manufacturer must also be able to have recourse to a combination of modules not using quality assurance, and vice versa, except where compliance with the requirements laid down by the directives requires the exclusive application of a certain procedure;
(k) for the purposes of operating the modules, Member States must notify on their own responsibility bodies under their jurisdiction which they have chosen from the technically competent bodies complying with the requirements of the directives. This responsibility involves the obligation for the Member States to ensure that the notified bodies permanently have the technical qualifications required by the directives and that the latter keep their competent national authorities informed of the performance of their tasks. Where a Member State withdraws its notification of a body, it must take appropriate steps to ensure that the dossiers are processed by another notified body to ensure continuity;
(l) in addition, with regard to conformity assessment, the sub-contracting of work shall be subject to certain conditions guaranteeing:
– the competence of the establishment operating as sub-contractor, on the basis of conformity with series EN 45 000 standards, and the capability of the Member State that has notified the sub-contracting body to ensure effective monitoring of such compliance,
– the ability of the body notified to exercise effective responsibility for the work carried out under sub-contract;
(m) notified bodies that can prove their conformity with harmonized standards (EN 45 000 series), by submitting an accreditation certificate or other documentary evidence, are presumed to conform to the requirements of the directives. Member States having notified bodies unable to prove their conformity with the harmonized standards (EN 45 000 series) may be requested to provide the Commission with the appropriate supporting documents on the basis of which notification was carried out;
(n) a list of notified bodies must be published by the Commission in the Official Journal of the European Communities and constantly updated.
B. The principal guidelines for the affixing and use of the CE marking are the following:
(a) The CE marking symbolizes conformity to all the obligations incumbent on manufacturers for the product by virtue of the Community directives providing for its affixing.
Thus, such conformity is not limited to the essential requirements relating to safety, public health, consumer protection, etc., as certain directives may impose specific obligations not necessarily forming part of the essential requirements.
(b) The CE marking affixed to industrial products symbolizes the fact that the natural or legal person having affixed or been responsible for the affixing of the said marking has verified that the product conforms to all the Community total harmonization provisions which apply to it and has been the subject of the appropriate conformity evaluation procedures.
(c) Where the industrial products are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the letter must indicate that the products are also presumed to conform to the provisions of those other directives.
However, where one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking indicates conformity to the provisions only of those directives applied by the manufacturer. In this case, particulars of the Directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices, or instructions accompanying the products or, where appropriate, on the data plate.
(d) 1. The CE conformity marking must consist of the initials ‘CE’ taking the following form:
If the CE marking is reduced or enlarged the proportions given in the above-graduated drawing must be respected.
2. Where the directive concerned does not impose specific dimensions, the CE marking must have a height of at least 5 mm.
3. The CE marking must be affixed to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents, where the directive concerned provides for such documents.
4. The CE marking must be affixed visibly, legibly, and indelibly.
(e) Any industrial product covered by the technical harmonization directives based on the principles of the global approach must bear the CE marking, save where the specific directives provide otherwise; such exceptions constitute derogations not from the marking requirement but from the administrative procedures for conformity evaluation, which may in certain cases be considered too cumbersome. Appropriate grounds must accordingly be given for any exception to or derogation from the marking requirement.
The CE marking is the only marking that certifies that the industrial products conform to the directives based on the principles of the global approach.
Member States must refrain from introducing into their national regulations any reference to conformity marking other than the CE marking in connection with conformity to all the provisions contained in the directives on CE marking.
(f) The CE marking must be affixed at the end of the production control phase.
(g) The CE conformity marking must be followed by the identification number of the notified body within the meaning of paragraph I.A where the said body is involved in the production control phase within the meaning of this Decision.
Such identification numbers must be assigned by the Commission as part of the body notification procedure. The Commission must publish lists of the notified bodies in the Official Journal of the European Communities; such lists must be updated regularly.
A notified body must be assigned the same number when it is notified under several directives. The Commission must ensure that each notified body receives a single identification number, however many directives it is notified under.
(h) It is necessary to lay down provisions concerning the use of certain products. In this case, the CE marking and the identification number of the notified body may be followed by a pictogram or any other mark indicating, for example, the category of use.
(i) The affixing for any other marking liable to deceive third-parties as to the meaning and form of the CE marking must be prohibited.
(j) A product may bear different marks, for example, marks indicating conformity to national or European standards or with traditional optional directives, provided such marks are not liable to cause confusion with the CE marking.
Such marks may therefore only be affixed to the product, it’s packaging, or the documentation accompanying the product on the condition that the legibility and visibility of the CE marking are not thereby reduced.
(k) The CE marking must be affixed by the manufacturer or his agent established within the Community. In exceptional, duly warranted cases, the specific directives may provide that the CE marking can be affixed by the person responsible for placing the product on the Community market.
The identification number of the notified body must be affixed under its responsibility either by the body itself or by the manufacturer or his agent established within the Community.
(l) Member States must take all provisions of national law necessary to exclude any possibility of confusion and to prevent abuse of the CE marking.
Without prejudice to the provisions in the directive concerned relating to the application of the safeguard clause, where a Member State establishes that the CE marking has been affixed unduly, the manufacturer, his agent or, exceptionally, where the specific directives so provide, the person responsible for placing the product in question on the Community market is obliged to make the product comply and to end the infringement under conditions imposed by the Member State. Where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in the safeguard clauses.

II. MODULES FOR CONFORMITY ASSESSMENT
Explanatory notes
Specific directives may allow the CE marking to be affixed to the packaging or the accompanying documentation, instead of to the product itself.
The declaration of conformity or the certificate of conformity (whichever of the two applies in the directive concerned) must cover either individual or several products and shall either accompany the product(s) covered or be kept by the manufacturer. The appropriate solution for the directive concerned will be specified.
References to Articles refer to the standard paragraphs of Annex II.B to the Council Resolution of 7 May 1985 (OJ No C 136, 4. 6. 1985, p. 1), which have become standard Articles in the ‘new approach’ directives.
The development of computerized communication of certificates and other documents issued by notified bodies is envisaged within INSIS.
Specific directives may use modules A, C, and H with additional provisions containing supplementary requirements which figure in the boxes in the modules.
Module C is designed to be used in combination with module B (EC type-examination). Modules D, E, and F will also normally be used in combination with module B; however, in special cases (for example, when dealing with certain products of very simple design and construction) they may be used on their own.

Module A (internal production control)
1. This module describes the procedure whereby the manufacturer or his authorized representative established within the Community, who carries out the obligations laid down in point 2, ensures and declares that the products concerned satisfy the requirements of the directive that apply to them. The manufacturer or his authorized manufacturer established within the Community must affix the CE marking to each product and draw up a written declaration of conformity.
2. The manufacturer must establish the technical documentation described in paragraph 3 and he or his authorized representative established with the Community must keep it for a period ending at least 10 years (2) after the last product has been manufactured at the disposal of the relevant national authorities for inspection purposes.
Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.
3. Technical documentation must enable the conformity of the product with the requirements of the directive to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture, and operation of the product (3).
4. The manufacturer or his authorized representative must keep a copy of the declaration of conformity with the technical documentation.
5. The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of the directive that apply to them.

COUNCIL DIRECTIVE 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member States relating to Electrical Equipment designed for use within certain voltage limits.

 

This directive has been amended by the following Council Directives: 1. 92/59/eec of 29 June 1992 (General Product Safety); 2. 93/68/eec of 22 July 1993 (CE Marking directive).Other Related CE Publications: 1. Guidelines to Low Voltage Directive (LVD) 73/23/eec 2. 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec 3. 89/336/eec: Directive of Electromagnetic Compatibility (EMC) 4. Guidelines to EMC Directive 89/336/eec 5. Technical-Aspects relating EMC Directive 89/336/eec 6. 2000 Framework of implementation of EMC Directive 89/336/EEC 7.  List of Harmonised (European) Standards 8.  List of Notified Bodies

 

1.	BackgroundThe Low Voltage Directive (LVD) was introduced at a time when directives contained detailed technical annexes which were intended to supersede national laws. The LVD set out the essential protection requirements, with the relevant technical details being defined by standards-making organizations. This subsequently paved the way for what was to be known as the New Approach Directives.
2.	Scope
2.1	The “Electrical Equipment” means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.). Therefore, this Directive is called often “Low Voltage Directive” which applies to the vast majority of electrical equipment in everyday use. The Electrical Equipment may be placed on the market only if it does not endanger the safety of persons, domestic animals, or property. There are 11 principal elements of the safety objectives listed in Annex I.
2.2	The Low Voltage Directive was the first directive to reference standards, and equipment that complies with harmonized safety standards drawn up by common agreement is deemed to comply. Where harmonized standards are not available, international standards which have been agreed to may be used.
2.3	The Low Voltage Directive has been in existence for over twenty years and, in conjunction with the CE Marking Directive 93/68/EEC which amended it as and from 1st January 1995, the note should be taken of some of its main features. (a) The Low Voltage Directive is not designed to impose safety standards. Its primary purpose is to ensure free trade through the removal of technical barriers. (b) Conformity with standards is not compulsory, but it can be used as one means to demonstrate compliance with the safety principles enshrined in the directive. (c) The Low Voltage Directive covers other aspects of safety, including mechanical aspects. (d) There are some items that are excluded from the Low Voltage Directives and those are listed in Annex II of the directive.
3.	Demonstrating Conformity
3.1	From a manufacturer’s perspective, a key element of the directive is to be found in article 10, which relates to proof of conformity. The Low Voltage Directive defines three means whereby such conformity can be demonstrated; manufacturer’s declaration, certificates, and notified body marks.
3.2	While the manufacturer’s declaration is in itself sufficient to provide an “a priori” presumption of conformity of the equipment to the directive (the equipment is deemed to comply unless the importing country can prove otherwise), he must be entirely satisfied that he is correct in this regard.
3.3	Today, when manufacturers are faced with highly competitive markets, shortening product life cycles, and continuing economic pressures, they are turning to independent certification agencies to provide the confidence and market advantage that is vital to their business needs. The certification agencies assist by issuing certificates in a recognized format, or by authorizing the use of a notified certification mark.These mechanisms for certification do not exist in isolation, as reciprocal recognition arrangements are in place between National Certification Bodies at a number of levels.
3.4	The IECEE scheme for the mutual recognition of test reports, and the CENELEC Certification Agreement (CCA) are implemented by many certification agencies.
3.5	On the 1st January 1995, the Amending CE Marking Directive 93/68/EEC came into force. Its purpose, as far as the LVD is concerned, is to modify the conformity assessment and marking provisions so that the LVD can be fully integrated into the new approach/global approach philosophy. (See Articles 13-15 of 93/68/EEC). From 1st January 1995 until 31st December 1996 a transitional arrangement applies in that products may be placed on the market if they comply with the marking requirements in force before 1st January 1995. Alternatively, manufacturers may follow the provisions of the Amending Directive and apply the CE Marking, making sure that it is clearly stated that the Marking is evidence of compliance under the LVD. This will permit free circulation, avoiding difficulties with national administrations. From 1st January 1997, application of the CE Marking will indicate that the equipment complies with the requirements of all relevant directives.
	ANNEX I 11 PRINCIPAL ELEMENTS OF THE SAFETY OBJECTIVES1. General conditions a) The essential characteristics, the recognition, and observance of which will ensure that electrical equipment will be used safely and in applications for which it was made, shall be marked on the equipment, or, if this is not possible, on an accompanying notice. b) The manufacturers or brand name or trademark should be clearly printed on the electrical equipment or, where that is not possible, on the packaging. c) The electrical equipment, together with its component parts should be made in such a way as to ensure that it can be safely and properly assembled and connected. d) The electrical equipment should be so designed and manufactured as to ensure that protection against the hazards set out in points 2 and 3 of this Annex is assured providing that the equipment is used in applications for which it was made and is adequately maintained.2. Protection against hazards arising from the electrical equipment Measures of a technical nature should be prescribed in accordance with point 1, in order to ensure: a) that persons and domestic animals are adequately protected against the danger of physical injury or other harm which might be caused by electrical contact direct or indirect; b) that temperatures, arcs, or radiation which would cause a danger, are not produced; c) that persons, domestic animals, and property are adequately protected against non-electrical dangers caused by the electrical equipment which are revealed by experience; d) that the insulation must be suitable for foreseeable conditions. 3. Protection against hazards that may be caused by external influences on the electrical equipment Technical measures are to be laid down in accordance with point 1, in order to ensure: a) that the electrical equipment meets the expected mechanical requirements in such a way that persons, domestic animals, and property are not endangered; b) that the electrical equipment shall be resistant to non-mechanical influences in expected environmental conditions, in such a way that persons, domestic animals, and property are not endangered; c) that the electrical equipment shall not endanger persons, domestic animals, and property in foreseeable conditions of overload. ANNEX II EQUIPMENT AND PHENOMENA OUTSIDE THE SCOPE OF THE DIRECTIVE Electrical equipment for use in an explosive atmosphere Electrical equipment for radiology and medical purposes Electrical parts for goods and passenger lifts Electricity meters Plugs and socket-outlets for domestic use Electric fence controllers Radio-electrical interference Specialized electrical equipment, for use on ships, aircraft, or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate.

CONTENTS   Introduction   The “Low Voltage” Directive   Scope of the “Low Voltage” Directive   Safety requirements for placing on the EU market electrical equipment covered by the “Low Voltage” Directive   Conformity Assessment Procedures under the “Low Voltage” Directive   Relationship between the “Low Voltage” Directive and certain other Community Directives I. INTRODUCTION These guidelines have been prepared with a view to assisting all parties directly or indirectly involved in the application of Directive 73/23/EEC, the “Low Voltage” Directive. They supersede guidance on the application of that Directive which was given in the Commission’s communication of 15 December 1981. They have been drawn up by European Commission services and discussed with a Working Party of Government Experts, representatives of European industry, and European standardization bodies. These guidelines reflect the consensus views reached between Commission services and representatives of the Member States in the Working Party. Readers’ attention is drawn to the fact that this Guide is intended only for facilitating the application of the “Low Voltage” Directive and it is the text of the Directive which is legally binding. This document is not a legally binding interpretation of the Directive. However, it represents a reference for ensuring consistent application of the Directive by all those involved. These guidelines are not exhaustive: they focus on certain issues only, which, in the light of the experience, are of direct and specific interest for the application of the “Low Voltage” Directive. They are intended to complement the “Guide to the implementation of Community harmonization directives”: published for the first time by the Commission in 1994, as far as issues related in particular to the application of this Directive are concerned. In particular, for the definitions of concepts like “placing on the market”, “manufacturer”, authorized representative”, “importer or person responsible for placing the product on the market”, the Guide mentioned above should be consulted. The issues covered by these guidelines are: the scope of the “Low Voltage” Directive the safety requirements applicable the conformity assessment procedure applicable, including CE marking the relationships with certain other Directives. Reader’s attention is drawn to the fact that certain products subject to the “Low Voltage” Directive are also subject to other directives. In order to be allowed on the EC market, these products must comply also with the provisions of those directives. These guidelines refer to the application of the “Low Voltage” Directive and clarify the relationship between that Directive and certain other directives. II. THE “LOW VOLTAGE” DIRECTIVE III. SCOPE OF THE “LOW VOLTAGE” DIRECTIVE Which products are covered? Are “components” included in the scope? Which safety aspects are covered by the Directive? IV. SAFETY REQUIREMENTS FOR PLACING ON THE EU MARKET ELECTRICAL EQUIPMENT COVERED BY THE “LOW VOLTAGE” DIRECTIVE Which are the mandatory safety requirements applicable in the EU? How to ensure conformity to those requirements? V. CONFORMITY ASSESSMENT PROCEDURES UNDER THE “LOW VOLTAGE” DIRECTIVE What are the conformity assessment procedures to be applied? What must be included in the technical documentation? Who must keep the technical documentation and where? This technical documentation must be kept within the Community. Where must the CE marking be affixed? What are the meaning of, and requirements for the CE marking? Who must keep the declaration of conformity and where? What must be included in the declaration of conformity? VI. RELATIONSHIPS BETWEEN THE “LOW VOLTAGE” DIRECTIVE AND CERTAIN OTHER COMMUNITY DIRECTIVES What are the requirements applicable to electrical equipment which is also a “machine” (within the meaning of the “Machinery Directive”)? What are the requirements applicable to electrical equipment which is intended for hire permanently incorporated in construction works? What are the relation between the “Telecommunication Terminal Equipment” and “Satellites” directives What is the relation with the “Gas Appliances” Directive

Our Anti-SPAM Policy:
Wellkang has a strict Anti-SPAM policy and Wellkang never sends out un-solicited SPAM messages!
To contact Wellkang via Internet, please always use our online feedback or inquiry forms. Do not send unsolicited emails to Wellkang, any un-solicited (including spam) emails will be deleted automatically and may never reach us. Our system blocks and deletes automatically, without notice to the sender, emails originated from known IP numbers and email addresses which have/had been used to send SPAM or junk emails. Wellkang can therefore not guarantee the receipt of any emails sent to us without using one of the online feedback or inquiry forms placed at any of Wellkang´s websites.

Ordering, Post-Sales Service, Repairing, Warranty, Claims, etc:
Wellkang is NOT involved in any way in either the Design/Manufacture/Test or Marketing/Distribution/Sales/Supply/Installation of any CE-marked product, for which Wellkang is the regulatory Authorised Representative (EC Rep) according to the Label, Package or Instruction For Use (IFU), therefore ALL matters regarding Placing an Order, Post-Sales Service, Repairing, Warranty, Claims, etc. should be addressed directly to either the Manufacturer or the Importer/Distributor according to the Label, Package or IFU, or the Supplier who has sold/supplied you with the product. A regulatory Authorised Representative (EC Rep) is NOT a Commercial Sales Representative.

Verification:
In order to fight against counterfeiting, and prevent fraud and forgery, Wellkang answers only inquiries submitted by using our online forms, we do NOT disclose our clients’ information over the phone. If you are importing/distributing/dealing with our clients (or a company who claims to be our client) and you want to verify whether or not Wellkang is the European Authorised Representative for a non-EU manufacturer, you must ask our client (the non-EU manufacturer) to introduce you to us, otherwise, we may be unable to answer your verification of our clients’ information. Furthermore, only buy medical devices from a legitimate manufacturer or supplier, if you are buying any CE-marked products online, such as via E-bay or Amazon, please always make sure that the seller is based within the EEA countries and the seller is either the genuine EEA manufacturer or a distributor/dealer authorized by the genuine EEA or non-EEA manufacturer, in accordance with the labeling. Please verify with the genuine manufacturer whether any online seller is authorized and make sure the product is aimed at the market where the buyer is located.

INCIDENT Reporting:
If you want to inform us about any INCIDENT caused by a CE-marked product, for which Wellkang is the Authorised Representative (EC Rep) according to the Label, Package or Instruction For Use (IFU), please send us fax immediately at no. +44(20)7681-1874 and provide us with at least the following information:
Product Name; Batch/LOT/Serial No.; Name of Manufacturer; Name of Importer or Distributor on the Label (if available); Description of the INCIDENT: Date, Place, What has happened, etc.

Warning & Alert:
We have become aware that there have been a number of cases where some companies are using falsified either CE marking certificates, EC Declaration of Conformity, or Labelling on which Wellkang is listed as the European Authorised Representative (EC Rep). Please be advised that Wellkang has NEVER issued ANY Certificate of Conformity or EC Certificate for CE Marking to ANY companies. For further details, please refer to Wellkang’s Warning & Notice.

CE Marking Inquiry:

If your question is WHETHER OR NOT your product will NEED CE marking and/or WHICH EU Directive may apply to your product(s), and you will most probably find the answer yourself.

If your question is about standard(s), for instance, WHICH European and/or international standard(s) may apply to your product(s), and find the answers.

If your question is about Notified Bodies and/or Testing Labs, for instance, WHETHER a Testing Lab is a Notified Body or WHETHER a Notified Body is authorized to issue certification(s) for a specific directive(s)/product(s), and find the answers.

CHAPTER I
Scope, placing on the market, and free movement

Article 1
1. This Directive applies to simple pressure vessels manufactured in series.
2. For the purposes of this Directive,
‘simple pressure vessel’ means any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired.
Moreover,
-the parts and assemblies contributing to the strength of the vessel under pressure shall be made either of non-alloy quality steel or of non-alloy aluminum or non-age hardening aluminum alloys,
-the vessel shall be made of:
-either a cylindrical part of circular cross-section closed by outwardly dished and/or flat ends which revolve around the same axis as the cylindrical part,
-or two dished ends revolving around the same axis,
-the maximum working pressure of the vessel shall not exceed 30 bar and the product of that pressure and the capacity of the vessel (PS.V) shall not exceed 10 000 bar/liter,
-the minimum working temperature must be no lower than minus 50 �C and the maximum working temperature shall not be higher than 300 �C for steel and 100 �C for aluminum or aluminum alloy vessels.
3. The following vessels shall be excluded from the scope of the Directive:
-vessels specifically designed for nuclear use, failure of which may cause an emission of radioactivity,
-vessels specifically intended for installation in or the propulsion of ships and aircraft,
-fire extinguishers.

Article 2
1. Member States shall take all necessary steps to ensure that the vessels referred to in Article 1, hereinafter referred to as ‘vessels’, may be placed on the market and taken into service only if they do not compromise the safety of persons, domestic animals or property when properly installed and maintained and when used for the purposes for which they are intended.
2. The provisions of this Directive do not affect the right of Member States to specify – with due observance of the Treaty – the requirements they deem necessary to ensure that workers are protected when using vessels, provided it does not mean the vessels are modified in a way unspecified in this Directive.

Article 3
1. Vessels in respect of which the product of PS and V exceeds 50 bar/liter must satisfy the essential safety requirements set out in Annex I.
2. Vessels in respect of which the product of PS and V is 50 bar/liter or less must be manufactured in accordance with sound engineering practice in one of the Member States and bear markings as laid down in section 1 of Annex II, with the exception of the EC mark referred to in Article 16.

Article 4
The Member States shall not impede the placing on the market and the taking into service in their territory of vessels which satisfy the requirements of this Directive.

Article 5
1. Member States shall presume compliance with the essential safety requirements referred to in Article 3 in respect of vessels bearing the EC mark denoting conformity with the relevant national standards incorporating the harmonized standards whose reference numbers have been published in the Official Journal of the European Communities. The Member States shall publish the reference numbers of such national standards.
2. Member States shall presume that vessels in respect of which the manufacturer has not applied, or has applied only in part, the standards referred to in paragraph 1, or for which no such standards exist, comply with the essential requirements referred to in Article 3 where, after receipt of an EEC type-examination certificate, their conformity with the approved model has been certified by the affixation of the EC mark.

Article 6
1. Where a Member State or the Commission, considers that the harmonized standards referred to in Article 5 (1) do not entirely meet the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Standing Committee set up under Directive 83/189/EEC, hereinafter referred to as ‘the committee, giving the reasons therefor. The committee shall deliver an opinion without delay. In the light of the committee’s opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the publications referred to in Article 5 (1).

Article 7
1. Where a Member State finds that vessels bearing the EC mark and used in accordance with their intended purpose might compromise the safety of persons, domestic animals or property, it shall take all appropriate measures to withdraw those products from the market or to prohibit or restrict they’re being placed on the market.
The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision, and in particular whether non-conformity is due to:
(a)failure to meet the essential requirements referred to in Article 3, where the vessel does not meet the standards referred to in Article 5 (1);
(b)incorrect application of the standards referred to in Article 5 (1);
(c)shortcomings in the standards referred to in Article 5 (1) themselves.
2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that any measure as referred to in paragraph 1 is justified, it shall immediately so inform the Member State that took the action and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission, after consulting the parties concerned, shall bring the matter before the Committee within two months if the Member State which has taken the measures intends to maintain them and shall initiate the procedures referred to in Article 6.
3. Where a vessel which does not comply bears the EC mark, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.

CHAPTER II
Certification procedures

Article 8
1. Prior to production of pressure vessels of which the product of PS and V exceeds 50 bar/liter, manufactured:
(a)in accordance with the standards referred to in Article 5 (1), the manufacturer, or his authorized representative established within the Community, shall at his own choice:
-either inform an approved inspection body as referred to in Article 9, which after examining the design and manufacturing schedule referred to in Annex II 3, shall draw up a certificate of adequacy attesting that the schedule is satisfactory, or
-submit a prototype vessel for the EC type-
the examination referred to in Article 10;
(b)not, or only partly, in accordance with the standards referred to in Article 5 (1), the manufacturer, or his authorized representative established within the Community, must submit a prototype vessel for the EC type-examination referred to in Article 10.
2. Vessels manufactured in accordance with the standards referred to in Article 5 (1) or with the approved prototype shall, prior to their being placed on the market, be subject:
(a)to the EC verification referred to in Article 11 where the product of PS and V exceeds 3 000 bar/liter:
(b)at the choice of the manufacturer, where the product
of PS and V does not exceed 3 000 bar liter but exceeds
50 bar/liter:
-either to the EC declaration of conformity referred to in Article 12, or
-to the EC verification referred to in Article 11.
3. The records and correspondence relating to the certification procedures referred to in paragraphs 1 and 2 shall be drafted in an official language of the Member State in which the approved body is established or in a language accepted by that body.

Article 9
1. Each Member State shall notify the Commission and the other Member States of the approved bodies responsible for carrying out the certification procedures referred to in Article 8 (1) and (2). The Commission shall publish a list of these bodies and the distinguishing number it has allotted them, for information purposes, in the Official Journal of the European Communities and shall ensure that the list is kept up to date.
2. Annex III sets out the minimum criteria which the Member States must meet as regards approval of these bodies.
3. A Member State which has approved a body must withdraw approval if it finds that the body no longer
meets the criteria listed in Annex III. It shall immediately
inform the Commission and the other Member States accordingly.
EC type-examination

Article 10
1. EC type-examination is the procedure by which an approved inspection body ascertains and certifies that a prototype vessel satisfies the provisions of this Directive that apply to it.
2. The application for EC type-examination shall be lodged by the manufacturer or by his authorized representative with a single approved inspection body in respect of a prototype vessel or of a prototype representing a family of vessels. That authorized representative must be established in the Community.
The application shall include:
-the name and address of the manufacturer or of his authorized representative and the place of manufacture of the vessels,
-the design and manufacturing schedule referred to in Annex II 3.
It shall be accompanied by a vessel that is representative of the production envisaged.
3. The approved body shall carry out the EC type-examination in the manner described below.
It shall examine not only the design and manufacturing schedule in order to check its conformity, but also the vessel submitted.
When examining the vessel, the body shall:
(a)verify that the vessel has been manufactured in conformity with the design and manufacturing schedule and may safely be used under its intended working conditions;
(b)perform appropriate examinations and tests to check that the vessel complies with the essential requirements applicable to it.
4. If the prototype complies with the provisions applicable to it the body shall draw up an EC type-examination certificate which shall be forwarded to the applicant. That certificate shall state the conclusions of the examination, indicate any conditions to which its issue may be subject, and be accompanied by the descriptions and drawings necessary for identification of the approved prototype.
The Commission, the other approved bodies, and the other Member States may obtain a copy of the certificate and, on a reasoned request, a copy of the design and manufacturing schedule and the reports on the examinations and tests carried out.
5. A body that refuses to issue an EC type-examination certificate shall so inform the other approved bodies. A body that withdraws an EC type-examination certificate shall so inform the Member State which approved it. The latter shall inform the other Member States and the Commission thereof, giving the reasons for the decision.
EC verification

Article 11
1. The purpose of EC verification is to check a certify that series-manufactured vessels comply with the standards referred to in Article 5 (1) or with the approved prototype. It shall be performed by an approved inspection body in accordance with the provisions set out below. That body shall issue an EC verification certificate and affix the mark of conformity provided for in Article 16.
2. Verification shall be performed on the batches of vessels submitted by their manufacturer or by his authorized representative established within the Community. Batches shall be accompanied by the EC type-examination certificate referred to in Article 10, or, if the vessels are not manufactured in accordance with an approved prototype, by the design and manufacturing schedule referred to in Annex II section 3. In the latter case, the approved body shall, prior to EC verification, examine the schedule in order to certify its conformity.
3. When a batch is examined, the inspection body shall ensure that the vessels have been manufactured and checked in accordance with the design and manufacturing schedule and shall perform a hydrostatic test or, a pneumatic test of an equivalent effect on each vessel in the batch at a pressure Ph equal to 1,5 times the vessel’s design pressure in order to check its soundness. The premature test shall be subject to acceptance of the test safety procedures by the Member States in which the test is performed. Moreover, the inspection body shall carry out tests on test pieces taken from a representative production test-piece or from a vessel, as the manufacturer chooses, in order to examine weld quality. The tests shall be carried out on longitudinal welds. However, where differing welding techniques are used for longitudinal and circular welds, the tests shall be repeated on the circular welds.
4. For the vessels referred to in section 2.1.2 of Annex I, these tests on test-pieces shall be replaced by a hydrostatic test on five vessels taken at random from each batch, in order to check that they conform to the requirements of section 2.1.2 of Annex I.
EC declaration of conformity

Article 12
1. A manufacturer fulfilling the obligations arising out
of Article 13 shall affix the EC mark provided for in
Article 16 to vessels which he declares to be in conformity with the standards, referred to in Article 5 (1) or with an approved prototype. By this EC declaration of conformity procedure, the manufacturer becomes subject to EC surveillance, in cases where the product of PS and V exceeds 200 bar/liter.
2. The purpose of EC surveillance is to ensure, as required by Article 14 (2), that the manufacturer duly fulfills the obligations arising out of Article 13 (2). Surveillance shall be performed by the approved body which issued the EC type-examination certificate referred to in Article 10 where the vessels have been manufactured in accordance with an approved prototype or, if this is not the case, by the approved body to which the design and manufacturing schedule was sent in accordance with Article 8 (1) (a), first indent.

Article 13
1. Where a manufacturer makes use of the procedure referred to in Article 12, he must, before commencing manufacture, send the approved body which issued the EC type-examination certificate or the certificate of adequacy a document describing the manufacturing processes and all of the pre-determined systematic measures taken to ensure conformity of the pressure vessels to the standards referred to in Article 5 (1) or the approved prototype.
This document shall include:
(a)a description of the means of manufacture and checking appropriate to the construction of the vessels:
(b)an inspection document describing the appropriate examinations and tests to be carried out during manufacture, together with the procedures therefore and the frequency with which they are to be performed;
(c)an undertaking to carry out the examinations and tests in accordance with the inspection document referred to above and to have a hydrostatic test or, subject to the agreement of the Member State, a pneumatic test carried out on each vessel manufactured at test pressure equal to 1,5 times the design pressure.
These examinations and tests shall be carried out under the responsibility of qualified staff who are sufficiently independent of production personnel, and shall be covered by a report;
(d)the addresses of the places of manufacture and storage and the date on which manufacture is to commence.
2. In addition, when the product of PS and V exceeds
200 bar/liter, manufacturers shall authorize access to the said places of manufacture and storage by the body responsible for EC surveillance, for inspection purposes, and shall allow that body to select sample vessels and shall provide it with all necessary information, and in particular:
-the design and manufacturing schedule,
-the inspection report,
-the EC type-examination certificate or certificate of adequacy, where appropriate,
-a report on the examinations and tests carried out.

Article 14
1. The approved body which issued the EC type-
examination certificate or certificate of adequacy must, before the date on which any manufacture begins, examine both the document referred to in Article 13 (1) and the design and manufacturing schedule referred to in Annex II, section 3, in order to certify their conformity where vessels are not manufactured in accordance with an approved prototype.
2. In addition, where the product of PS and V exceeds 200 bar/liter, that body must during manufacture:
-ensure that the manufacturer actually checks series-produced vessels in accordance with Article 13 (1) (c),
-take random samples at the places of manufacture or at the place of storage of vessels for inspection purposes.
The body shall supply the Member State which approved it, and, on request, the other approved bodies, the other Member States and the Commission, with a copy of the inspection report.

COUNCIL DIRECTIVE of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys (88/378/EEC)

 

Article 1

1. This Directive shall apply to toys.
A toy shall mean any product or material designed or clearly intended for use in play by children of less than 14 years of age.
2. The products listed in Annex I shall not be regarded as toys for the purposes of this Directive.

Article 2

1. Toys may be placed on the market only if they do not jeopardize the safety and/or health of users or third parties when they are used as intended or in a foreseeable way, bearing in mind the normal behavior of children.
2. In the condition in which it is placed on the market, taking account of the period of foreseeable and normal use, a toy must meet the safety and health conditions laid down in this Directive.
3. For the purposes of this Directive, the expression �placed on the market‘ shall cover both sale and distribution free of charge.

Article 3

Member States shall take all steps necessary to ensure that toys cannot be placed on the market unless they meet the essential safety requirements set out in Annex II.

Article 4

The Member States shall not impede the placing on the market on their territory of toys which satisfy the provisions of this Directive.

Article 5

Article 6

Article 7

Article 8

1. (a) Before being placed on the market, toys manufactured in accordance with the harmonized standards referred to in Article 5 (1) must have affixed to them the EC mark by which the manufacturer or his authorized representative established within the Community confirms that the toys comply with those standards;
(b) The manufacturer or his authorized representative established within the Community shall keep the following information available for inspection:
– a description of the means (such as the use of a test report or technical file) whereby the manufacturer ensures conformity of production with the standards referred to in Article 5 (1) and, as appropriate: an EC type-certificate drew up by an approved body; copies of the documents the manufacturer has submitted to the approved body; a description of the means whereby the manufacturer ensures conformity with the approved model,
– the addresses of the places of manufacture and storage,
– detailed information concerning the design and manufacture.
Where neither the manufacturer nor his authorized representative is established within the Community, the above obligation to keep a dossier available shall be the responsibility of the person who places the toy on the Community market.
2. (a) Toys which do not conform in whole or in part to the standards referred to in Article 5 (1) must have affixed to them, before being placed on the market, the EC mark by which the manufacturer or his authorized representative established within the Community confirms that the toy concerned conforms to the model examined in accordance with the procedures laid down in Article 10 which an approved body has stated complies with the essential requirements referred to in Article 3;
(b) the manufacturer or his authorized representive established within the Community shall keep the following information available for inspection:

1. – a detailed description of manufacture,
2. – a description of the means (such as the use of a test report or technical file) whereby the manufacturer ensures conformity with the approved model,
3. – the addresses of the places of manufacture and storage,
4. – copies of the documents the manufacturer has submitted to an approved body in accordance with Article 10 (2),
5. – the test certificate for the sample or a certified copy thereof.

Where neither the manufacturer nor his authorized representative is established within the Community, the above obligation to keep a dossier available shall be the responsibility of the person who places the toy on the market in the Community.
3. In the event of non-observance of the obligations laid down in paragraphs 1 (b) and 2 (b), the competent Member State shall take appropriate measures to ensure that those obligations are observed.
Where non-observance of the obligations is obvious, it may, in particular, require the manufacturer or his authorized representative established within the Community to have a test performed at his own expense within a specified period by an approved body in order to verify compliance with the harmonized standards and essential safety requirements.

Article 9

Article 10

Article 11

1. The EC mark referred to in Articles 5, 7, and 8 and the name and/or trade name and/or mark and address of the manufacturer or his authorized representative or the importer into the Community shall, as a rule, be affixed either to the toy or on the packaging in a visible, easily legible and indelible form. In the case of small toys and toys consisting of small parts, these particulars may be affixed in the same way to the packaging, to a label, or to a leaflet. Where the said particulars are not affixed to the toy, the consumer’s attention must be drawn to the advisability of keeping them.
2. The EC mark shall consist of the symbol �CE’.
3. The affixing to toys of marks or inscriptions that are likely to be confused with the EC mark shall be prohibited.
4. The particulars referred to in paragraph 1 may be abbreviated provided that the abbreviation enables the manufacturer, his authorized representative, or the importer into the Community to be identified.
5. Annex IV sets out the warnings and indications of precautions to be taken during use that have to be given for certain toys. Member States may require that these warnings and precautions, or some of them, together with the information specified in paragraph 4, be given in their own national language or languages when the toys are placed on the market.

Article 12

Article 13

 

Article 14

 

Article 15

 

Article 16

ANNEX I
PRODUCTS NOT REGARDED AS TOYS FOR THE PURPOSE OF THIS DIRECTIVE (Article 1 (1))

1. Christmas decorations
2. Detailed scale models for adult collectors
3. Equipment intended to be used collectively in playgrounds
4. Sports equipment
5. Aquatic equipment intended to be used in deep water
6. Folk dolls and decorative dolls and other similar articles for adult collectors
7. �Professional’ toys installed in public places (shopping centers, stations, etc.)
8. Puzzles with more than 500 pieces or without a picture, intended for specialists
9. Air guns and air pistols
10. Fireworks, including percussion caps (�)
11. Slings and catapults
12. Sets of darts with metallic points
    1. Electric ovens, irons or other functional products operated at a nominal voltage exceeding 24 volts
    2. Products containing heating elements intended for use under the supervision of an adult in a teaching context
    3. Vehicles with combustion engines
    4. Toy steam engines
    5. Bicycles designed for sport or for travel on the public highway
    6. Video toys that can be connected to a video screen, operated at a nominal voltage exceeding 24 volts
    7. Babies’ dummies
    8. Faithful reproductions of real firearms
    9. Fashion jewelry for children (�) With the exception of percussion caps specifically designed for use in toys without prejudice to more stringent provisions already existing in the certain Member States.

    ANNEX II
    ESSENTIAL SAFETY REQUIREMENTS FOR TOYS

    I. GENERAL PRINCIPLES
    II. PARTICULAR RISKS

CHAPTER I
Field of application – Definitions – Requirements Technical specifications – Free movement of goods

Article 1

1. This Directive shall apply to construction products in so far as the essential requirements in respect of construction works under Article 3 (1) relate to them
2. For the purposes of this Directive,
‘construction product’ means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works.
‘Construction Products’ are hereinafter referred to as ‘products’; construction works including both buildings and civil engineering works are hereinafter referred to as ‘works’.

Article 2

1. The Member States shall take all necessary measures to ensure that the products referred to in Article 1, which are intended for use in works, may be placed on the market only if they are fit for this intended use, that is to say, they have such characteristics that the works in which they are to be incorporated, assembled, applied or installed, can if properly designed and built, satisfy the essential requirements referred to in Article 3 when and where such works are subject to regulations containing such requirements.
2. When products are subject to other Community directives with regard to other aspects, the EC conformity mark, hereinafter referred to as the ‘EG mark’, referred to in Article 4 (2) shall indicate in these cases that the requirements of those other directives have also been complied with.
3. When a future directive concerns mainly other aspects and only to a minor extent the essential requirements of this Directive, that subsequent directive shall contain provisions ensuring that it also covers the requirements of this Directive.
4. This Directive shall not affect the right of Member States to specify – with due observance of the provisions of the Treaty – the requirements they deem necessary to ensure that workers are protected when using products, provided it does not mean the products are modified in a way unspecified in this Directive

Article 3

1. The essential requirements applicable to works that may influence the technical characteristics of a product are set out in terms of objectives in Annex I. One, some or all of these requirements may apply; they shall be satisfied during an economically reasonable working life.
2. In order to take account of possible differences in geographical or climatic conditions or in ways of life as well as different levels of protection that may prevail at the national, regional, or local level, each essential requirement may give rise to the establishment of classes in the documents referred to in paragraph 3 and the technical specifications referred to in Article 4 for the requirement to be respected.
3. The essential requirements shall be given concrete form in documents (interpretative documents) for the creation of the necessary links between the essential requirements laid down in paragraph 1 and the standardization mandates, mandates for guidelines for European technical approval, or the recognition of other technical specifications within the meaning of Articles 4 and 5.

Article 4

1. Standards and technical approvals shall, for the purposes of this Directive, be referred to as ‘technical specifications’
For the purposes of this Directive, harmonized standards shall be the technical specifications adopted by CEN, Cenelec, or both, on mandates given by the Commission in conformity with Directive 83/189/EEC on the basis of an opinion given by the Committee referred to in Article 19 and in accordance with the general provisions concerning cooperation between the Commission and these two bodies signed on 13 November 1984.
2. Member States shall presume that the products are fit for their intended use if they enable works in which they are employed, provided the latter are properly designed and.
built, to satisfy the essential requirements referred to in Article 3, and those products bear the EC mark. The EC mark shall indicate:
(a) that they comply with the relevant national standards transposing the harmonized standards, references to which have been published in the Official Journal of the European Countries. The Member States shall publish the references of these national standards:
(b) that they comply with a European technical approval, delivered according to the procedure of Chapter III, or
(c) that they comply with the national technical specifications referred to in paragraph 3 in as much as harmonized specifications do not exist; a list of these national specifications shall be drawn up according to the procedure in Article 5 (2). 3. Member States may communicate to the Commission the texts of their national technical specifications which they regard as complying with the essential requirements referred to in Article 3. The Commission shall forward these national technical specifications forthwith to the other Member States. In accordance with the procedure provided for in Article 5 (2), it shall notify the Member States of those national technical specifications in respect of which there is a presumption of conformity with the essential requirements referred to in Article 3.
This procedure will be initiated and managed by the Commission in consultation with the committee referred to in Article 19
The Member States shall publish the references to these technical specifications. The Commission shall also publish them in the Official Journal of the European Countries
4. Where a manufacturer, or his agent, established in the Community, has not applied or has applied only in part, the existing technical specifications referred to in paragraph 2, which require, according to the criteria set out in Article 13 (4), the product to be submitted for a declaration of conformity as defined in Annex III (2) (ii), second and third possibilities, the corresponding decisions under Article 13 (4) and Annex III shall apply and such a product’s fitness for use within the meaning of Article 2 (1) shall be established in accordance with the procedure set out in Annex III (2) (ii), second possibility.
5. The Commission, in consultation with the committee referred to in Article 19, shall draw up, manage and revise periodically a list of products that play a minor part with respect to health and safety and in respect of which a declaration of compliance with the ‘acknowledged rule of technology’, issued by the manufacturer, will authorize such products to be placed on the market.
6. The EC mark signifies that products satisfy the requirements of paragraphs 2 and 4 of this Article. It is for the manufacturer, or his agent established in the Community, to take responsibility for affixing the EC mark on the product itself, on a label attached to it, on its packaging, or on the accompanying commercial documents.
The model of the EC mark and conditions of its use are given in Annex III.
products referred to in paragraph 5 shall not bear the EC mark.

Article 5

1. Where a Member State or the Commission is of the opinion that the harmonized standards or European technical approvals referred to in Article 4 (2), points (a) and (b), or the mandates referred to in Chapter II, do not satisfy the provisions of Articles 2 and 3, that Member State or the Commission shall notify the committee referred to in Article 19, setting out its reasons. The committee shall deliver an urgent opinion.
In the light of the opinion of the committee, and after consultation with the committee set up under Directive 83/189/EEC where it concerns harmonized standards, the Commission shall inform the Member States if the standards or approvals concerned should be withdrawn in the publications referred to in Article 7 (3).
2. On reception of the communication referred to in Article 4 (3), the Commission shall consult the committee referred to in Article 19. In the light of the opinion of the committee, the Commission shall notify the Member States whether the technical specification in question should benefit from the presumption of conformity and, if so, publish a reference to it in the Official Journal of the European Countries.
If the Commission or a Member State believes that a technical specification no longer fulfills the conditions necessary for the presumption of conformity with the provisions of Articles 2 and 3, the Commission shall consult the committee referred to in Article 19. In the light of the opinion of the said committee, the Commission shall notify the Member States whether the national technical specification in question should continue to benefit from the presumption of conformity, and, if not, whether the reference to it referred to in Article 4 (3) should be withdrawn.

Article 6

1. Member States shall not impede the free movement, placing on the market or use in their territory of products which satisfy the provisions of this Directive
The Member States shall ensure that the use of such products, for the purpose for which they were intended, shall not be impeded by rules or conditions imposed by public bodies or.
private bodies acting as a public undertaking or acting as a public body on the basis of a monopoly position.
2. Member States shall, however, allow products not covered by Article 4 (2)to be placed on the market in their territory if they satisfy national provisions consistent with the Treaty until the European technical specifications referred to in Chapters II and III provide otherwise. The Commission and the committee referred to in Article 19 will monitor and review the development of the European technical specifications on a regular basis.
3. If the relevant European technical specifications, either themselves or on the basis of the interpretative documents referred to in Article 3 (3), distinguish between different classes corresponding to different performance levels, Member States may determine the performance levels also to be observed in their territory only within the classifications adopted at the Community level and only subject to the use of all or some classes or one class.

CHAPTER II
Harmonized standards

Article 7

1. In order to ensure the quality of harmonized standards for products, the standards shall be established by the European standards organizations on the basis of mandates given by the Commission in accordance with the procedure laid down in Directive 83/189/EEC and, after consulting the committee referred to in Article 19, in accordance with the general provisions concerning cooperation between the Commission and these bodies signed on 13 November 1984.
2. The resulting standards shall be expressed as far as practicable in product performance terms, having regard to the interpretative documents.
3. Once the standards have been established by the European standards organizations, the Commission shall publish the references of the standards in the ‘C’ series of the Official Official Journal of the European Countries.

CHAPTER III
European technical approval

CHAPTER IV
Interpretative documents

CHAPTER V
Attestation of conformity

Article 13

1. The manufacturer, or his agent established in the Community, shall be responsible for the attestation that products are in conformity with the requirements of a technical specification within the meaning of Article 4.
2. Products that are the subject of attestation of conformity shall benefit from the presumption of conformity with technical specifications within the meaning of Article 4. Conformity shall be established by means of testing or other evidence on the basis of the technical specifications in accordance with Annex III.
3. The attestation of conformity of a product is dependent on:
(a) the manufacturer having a factory production control system to ensure that production conforms with the relevant technical specifications; or
(b) for particular products indicated in the relevant technical specifications, in addition to a factory production control system, an approved certification body being involved in assessment and surveillance of the production control or of the product itself.
4. The choice of the procedure within the meaning of paragraph 3 for a given product or family of products shall be specified by the Commission, after consultation of the committee referred to in Article 19, according to:
(a) the importance of the part played by the product with respect to the essential requirements, in particular, those relating to health and safety;
(b) the nature of the product;
(c) the effect of the variability of the product’s characteristics on its serviceability;
(d) the susceptibility to defects in the product manufacture;
in accordance with the particulars set out in Annex III.
In each case, the least onerous possible procedure consistent with safety shall be chosen.
The procedure thus determined shall be indicated in the mandates and in the technical specifications or in the publication thereof.
5. In the case of individual (and non-series) production, a declaration of conformity in accordance with Annex III (2) (ii), a third possibility, shall suffice, unless otherwise provided by the technical specifications for products that have particularly important implications for health and safety.

Article 14

1. In accordance with Annex III, the procedures described shall lead to:
(a) in the case of Article 13 (3) (a), to the production of a declaration of conformity for a product by the manufacturer, or his agent established in the Community; or
(b) in the case of Article 13 (3) (b), to the issue by an approved certification body of a certificate of conformity for a system of production control and surveillance or for the product itself.
Detailed rules for the implementation of the procedures of attestation of conformity are given in Annex III.
2. The manufacturer’s declaration of conformity or the certificate of conformity shall entitle the manufacturer, or his agent established in the Community, to affix the corresponding EC mark on the product itself, on a label attached to it, on its packaging or on the accompanying commercial documents. The model of the EC mark and the rules for its use in respect of each of the procedures of attestation of conformity are given in Annex III.

Article 15

1. Member States shall ensure that the EC mark is correctly used.
2. Where it is established that the EC mark has been affixed to a product which does not satisfy, or no longer satisfies, this Directive, the Member State in which conformity was attested shall ensure that, if necessary, the use of the EC mark is forbidden and unsold products are withdrawn, or marks obliterated, until such time as the product concerned is brought back to conformity
The Member State concerned shall immediately inform the other Member States and the Commission, giving all the qualitative and quantitative details necessary to identify the product which does not conform.
3. Member States shall ensure that the affixing to products or their packing of marks that are likely to be confused with the EC mark shall be prohibited.

Background
1.1	The EMC Directive (89/336/EEC) is primarily concerned with removing trade barriers in the area of electromagnetic compatibility and, being a total harmonization directive, replaces national provisions where they previously existed. It is a new approach directive, which means that it lays down mandatory essential requirements and describes the methods by which conformity with these requirements can be demonstrated.
1.2	The directive relies on the availability of harmonized standards that provide test methods and limits, and significant work has been done to provide such methods and limits for the major industrial sectors.
2	Scope
2.1	The following represents a necessarily brief overview of the subject. The text of the directive is at all times the definitive guide to its requirements. Under its terms apparatus shall be constructed so that; a) the electromagnetic disturbance it generates does not exceed a level allowing radio and telecommunication equipment and other apparatus to operate as intended, and that b) the apparatus has an adequate level of intrinsic immunity to electromagnetic disturbance to enable it to operate as intended.
2.2	There have been difficulties in establishing exactly what equipment comes within the scope of the directive, and in October 1993 the Commission published “Guidelines on the Application of the Council Directive 89/336/EEC”
2.3	The directive applies to ‘all electrical and electronic appliances’ together with equipment and installations containing electrical and/or electronic components liable to cause an electromagnetic disturbance, and the performance of which is liable to be affected by such disturbance.
2.4	In order to clarify this point, the guideline document defines a ‘non-restrictive but comprehensive range of equipment which must be considered as being covered by the directive, as follows:-
	a) Emission and Immunity aspects I. Telecommunications terminal equipment (in so far as the protection requirements are not peculiar to this equipment) (see 13th recital of Directive 91/263/EEC).; [Note: “recital” is a reference to the numerous clauses commencing with the word “whereas”, with which Directives begin.] II. Electrical household appliances, portable tools, and similar equipment (last recital of the EMC Directive and Annex III (g)); III. Radio equipment used by radio amateurs if it is available commercially (Article 2(3) and Annex III (c) and (d)); IV. Radio and television receivers (Annex III (a)); V. Aeronautical and marine radio apparatus (Annex III (h)); VI. Radio and television broadcast transmission (Annex III (k)); VII. Fluorescent lighting luminaries fitted with starters (last recital of the relevant Directive); VIII. Lights and Fluorescent lamps (Annex III (I)); IX. Industrial equipment (Annex III (b)); X. Telecommunications apparatus (Annex III (j)); XI. Information technology equipment (Annex III (f)); XII. Educational electronic equipment (Annex III (i));   b) Emission aspect only. I. Non-automatic weighing instruments (immunity aspect is covered by Annex I, paragraph 8(2), Directive 90/384/EEC)   c) Immunity aspect only I. Agricultural and forestry tractors (the emission aspect is covered by Directive 75/322/EEC).
2.5	The following is a non-restrictive list of apparatus specifically excluded from the scope of the directive.
	a) Emission and immunity aspects I. Radio equipment used by radio amateurs unless the apparatus is commercially available (Article 2 (3)). II. Motor vehicles (covered by Directive 72/245/EEC). III. Active implantable medical devices (covered by Specific Directive 90/385/EEC). IV. Medical devices (covered by Directive 93/42/EEC). b) Emission aspects only I. Agricultural or forestry tractors (covered by Directive 75/332/EEC). c) Immunity aspects only I. Non-automatic weighing instruments (covered by Annex 1, para 8 (90/384/EEC).
3	Definitions
3.1	Some important definitions are listed below
	a) ManufacturerThe person who accepts responsibility for the design and manufacture of a product covered by the directive with a view to placing it on the Community market on his own behalf. As part of this responsibility, he takes on the obligation. to design and manufacture the product in line with the essential requirements of the directive. to follow the relevant conformity assessment procedures as detailed in the directive.   b) An authorized representative is the person who is expressly appointed by the manufacturer and who acts on his behalf in respect of certain obligations laid down under the directive. c) ImporterThis is the person who places on the Community Market products covered by the directive and imported and a third country. The importer must keep the manufacturer’s declaration of conformity and technical file at the disposal of the authorities, where neither the manufacturer nor his authorized representative is established within the Community. (Article 10(1) 3rd paragraph and Article 10(2), 3rd paragraph). d) The components directive does not apply to components, which are defined as any item which is used in the composition of an apparatus and which is not itself an apparatus with an intrinsic function intended for the final consumer. e) ApparatusThe directive applies to all apparatus as defined in the directive: that is, a finished product with an intrinsic function intended for the final user and intended to be placed on the market as a single commercial unit. The term equipment is synonymous with an apparatus. f) SystemsThe directive applies to systems, which are several items of apparatus combined to fulfill a specific objective and intended to be placed on the market as a single functional unit. g) InstallationsThe directive does not apply to installations, which are defined as several combined items of apparatus or systems put together at a given place to fulfill a specific objective but not intended to be placed on the market as a single functional unit. Apparatus and systems which make up the installation are however subject to the provisions of the Directive. h) Placing a product on the market means the first making available against payment, or free of charge, of a product covered by the directive in the Community Market for the purpose of distribution and/or use on the Community territory. i) Putting into service this means the first use on the Community territory, by its final user, of a product referred to in the directive.
4	Conformity Assessment
4.1	Conformity assessment is the means of demonstrating that the apparatus complies with the essential requirements of the directive. These means are described in Article 10 of the Directive. Article 10 describes the procedure by which the manufacturer applies harmonized standards. This is a self-certification approach, whereby having satisfied himself that this equipment complies with the relevant harmonised standards, the manufacturer makes a declaration of conformity as defined in Annex I(I) and applies the CE Marking. (This follows Module A of the Council Directive 93/465/EEC on page 5 of this document).
4.2	Article 10(2) describes the procedure where the manufacturer has not applied the standards or has applied them only in part, or in the absence of relevant standards. Under these circumstances, the manufacturer compiles a technical construction file containing all the relevant technical data required to assess the product. The file must include a certificate or technical report from a Competent Body, confirming compliance with the relevant standards.
4.3	Having satisfied himself that the equipment complies with the directive’s requirements, the manufacturer draws up the declaration of conformity ( Annex I(I) ) and applies the CE Marking. This also follows Module Aa of Directive 93/465/EEC. (Page 5).
4.4	Under each approach, the manufacturer must take all measures necessary to ensure that products within the scope of the directive comply with the protection requirements described in the declaration of conformity in the former case, and the technical construction file and the applicable requirements of relevant standards in the latter.
5	Article 10 (5)
5.1	This article concerns equipment designed for the transmission of radio communications. The manufacturer must obtain an EC Type-Examination certificate from a Notified Body, and declare that his series-manufactured products conform to the type as described in the certificate, and ensure that they satisfy the protection requirement of the directive. He then declares conformity with the directive (Annex I(I) ) and applies the CE Marking.
6	Bodies defined under the EMC Directive
6.1	Competent AuthoritiesThese is the administrations of the Member States which are responsible for Market Control.
6.2	Competent BodiesThe EMC Directive defines a body as competent if it fulfills the Annex II of the Directive criteria. They are presumed competent if they can prove their conformity with the appropriate harmonized standard of the EN 45000 series. The Competent body issues the technical reports or certificates referred to in Article 10 (2) of the Directive. The “guideline document” lists the known Competent Bodies.
6.3	Notified bodies must fulfill the requirements as set out in Annex II of the directive. It must be able to furnish proof that it conforms to the appropriate harmonized standards in the EN 45001.
7	Implementation
7.1	The provisions of this directive have applied since 1st January 1992. However, due to its wide scope, it was necessary to introduce a transitional period in order to ensure that a smooth changeover from purely national systems to an exclusively community-wide system took place. On 28th April 1992, the Council adopted Directive 92/31/EEC to allow a transitional period until 31st December 1995. During this transitional period, national systems may continue to be used, alongside the system given in the directive. Since 1st January 1996, the EMC Directive has become mandatory.

Chapter 1: Introduction Chapter 2: Objective of the EMC Directive Chapter 3: Definitions Chapter 4: Key articles of the EMC Directive with regard to its scope Chapter 5: Scope of the Directive Chapter 6: Application of the Directive to components, finished products, systems, and installations Chapter 7: Application of the Directive to used, second hand, and repaired apparatus, and to spare parts Chapter 8: Procedures for assessment of conformity Chapter 9: EC Declaration of conformity Chapter 10: Instructions for use Chapter 11: Competent Authorities, Competent Bodies, and Notified Bodies Chapter 12: Apparatus marking Chapter 13: Safeguard clause Chapter 14: Progress in standardization Chapter 15: Application of the Directive to some specific cases

ANNEX 1:
ANNEX 2:
ANNEX 3: References of national transposition of the EMC Directive
ANNEX 4: Competent authorities
ANNEX 5: List of competent bodies known to the Commission
ANNEX 6: List of notified bodies notified to the Commission
ANNEX 7: Harmonized standards published in the Official Journal of the European Communities
ANNEX 8: Standardization program for the development of harmonized standards
ANNEX 9: Useful addresses

EU Commission Communication in framework of implementation of   Directive 89/336/EEC  Electromagnetic Compatibility (EMC)

Offical Journal C099(2000) p0003-0018

Article 1

1. This Directive applies to personal protective equipment, hereinafter referred to as ‘PPE’.
It lays down the conditions governing its placing on the market and free movement within the Community and the basic safety requirements which PPE must satisfy in order to ensure the health protection and safety of users.

2. For the purposes of this Directive, PPE shall mean any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.
PPE shall also cover:
(a) a unit constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks;
(b) a protective device or appliance combined, separably or inseparably, with personal non-protective equipment
worn or held by an individual for the execution of a specific activity;
(c) interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment.

3. Any system placed on the market in conjunction with PPE for its connection to another external, additional device shall be regarded as an integral part of that equipment even if the system is not intended to be worn or held permanently by the user for the entire period of risk exposure.

4. This Directive does not apply to:
– PPE covered by another directive designed to achieve the same objectives as this Directive with regard to placing on the market, free movement of goods and safety,
– the PPE classes specified in the list of excluded products in Annex I, independently of the reason for exclusion mentioned in the first indent.

Article 2

Article 3

Article 4

1. Member States shall not prohibit, restrict or hinder the placing on the market of PPE or PPE components that satisfy the provisions of this Directive and which bear the EC mark.

Article 5

Article 6

Article 7

CHAPTER II

CERTIFICATION PROCEDURES

Article 8

1. Before placing a PPE model on the market, the manufacturer or his authorized representative established in the Community shall assemble the technical documentation referred to in Annex III so that this can, if necessary, be submitted to the competent authorities.

2. Prior to the series production of PPE other than those referred to in paragraph 3, the manufacturer or his authorized representative established in the Community shall submit a model for EC type-examination as referred to in Article 10.

3. EC type-examination shall not be required in the case of PPE models of simple design where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerned the effects of which, when they are gradual, can be safely identified by the user in good time.
This category shall cover exclusively PPE intended to protect the wearer against:
– mechanical action whose effects are superficial (gardening gloves, thimbles, etc.),
– cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.),
– risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50 GC or to dangerous impacts (gloves, aprons for professional use, etc.),
– atmospheric agents of neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.),
– minor impacts and vibrations which do not affect vital areas of the body and whose effects cannot cause irreversible lesions (light anti-scalping helmets, gloves, light footwear, etc.),
– sunlight (sunglasses).

4. Production of PPE shall be subject:
(a) according to the manufacturer’s choice, to one of the two procedures referred to in Article 11 in the case of PPE of complex design intended to protect against mortal danger or against dangers that may seriously and irreversibly harm the health, the immediate effects of which the designer assumes the user cannot identify insufficient time. This category shall cover exclusively:
– filtering respiratory devices for protection against solid and liquid aerosols or irritant, dangerous, toxic or radiotoxic gases,
– respiratory protection devices providing full insulation from the atmosphere, including those for use in diving,
– PPE providing only limited protection against chemical attack or against ionizing radiation,
– emergency equipment for use in high-temperature environments the effects of which are comparable to those of an air temperature of 100 GC or more and which may or may not be characterized by the presence of infra-red radiation, flames, or the projection of large amounts of molten material,
– emergency equipment for use in low-temperature environments the effects of which are comparable to those of an air temperature of 50 GC or less,
– PPE to protect against falls from a height,
– PPE against electrical risks and dangerous voltages or that used as insulation in high-tension work,
– motorcycle helmets and visors;
(b) the EC declaration of conformity referred to in Article 12 for all PPE.

Article 9

EC TYPE-EXAMINATION

Article 10

1. EC type-examination is the procedure whereby the approved inspection body establishes and certifies that the PPE model in question satisfies the relevant provisions of this Directive.

2. Application for EC type-examination shall be made by the manufacturer or his authorized representative to a single approved inspection body in respect of the model in question. The authorized representative shall be established in the Community.

3. The application shall comprise:
– the name and address of the manufacturer or his authorized representative and of the PPE production plant in question,
– the manufacturer’s technical file referred to in
Annex III.
It shall be accompanied by the appropriate number of specimens of the model to be approved.

4. The inspection body of which notification has been given shall conduct the EC type-examination in accordance with the undermentioned procedures:
(a) Examination of the manufacturer’s technical file
– It shall examine the manufacturer’s technical file to establish its suitability with respect to the harmonized standards referred to in Article 5.
– Where a manufacturer has not applied or has only partly applied, the harmonized standards or where there are no such standards, the body of which notification has been given must check the suitability of the technical specifications used by the manufacturer with respect to the basic requirements before examining the manufacturer’s technical file to establish its suitability with respect to these technical specifications.
(b) Examination of the model
– When examining the model, the inspection body shall verify that it has been produced in accordance with the manufacturer’s technical file and can be used in complete safety for its intended purpose.
– It shall conduct the necessary examinations and tests to establish the conformity of the model with the harmonized standards.
– Where a manufacturer has not applied or has only partly applied the harmonized standards or where there are no such standards the body of which notification has been given shall conduct the necessary examinations and tests to establish the conformity of the model with the technical specifications used by the manufacturer, subject to their being suitable with respect to these basic requirements.

5. If the model satisfies the relevant provisions, the inspection body shall draw up an EC type-examination certificate and shall notify the applicant to this effect. This certificate shall reproduce the findings of the examination, indicate any conditions attaching to its issue, and incorporate the descriptions and drawings necessary for the identification of the approved model.
The Commission, the other approved inspection bodies, and the other Member States may obtain a copy of the certificate and, in response to a reasoned request, a copy of the manufacturer’s technical file and the reports of the examinations and tests conducted.
The file shall be held at the disposal of the competent authorities for 10 years following the placing of the PPE on the market.

6. Any inspection body which refuses to issue an EC type-examination certificate shall inform the other approved inspection bodies of this fact. An inspection body withdrawing an EC type-examination certificate shall inform the Member State which approved it, to this effect. That Member State shall then inform the other Member States and the Commission, setting out the reasons for the decision.