
DECISION No 768/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (Text with EEA relevance) (revoked) 

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General principles
Article 1 
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Subject matter and scope
Article 2 
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Level of protection of public interests
Article 3 
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Conformity assessment procedures
Article 4 
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EC declaration of conformity
Article 5 
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Conformity assessment
Article 6 
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Reference provisions
Article 7 
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Repeal
Article 8 
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ANNEX I
REFERENCE PROVISIONS FOR COMMUNITY HARMONISATION LEGISLATION FOR PRODUCTS
Chapter R1
Definitions
Definitions
Article R1 
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Chapter R2
Obligations of economic operators
Obligations of manufacturers
Article R2 
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Authorised representatives
Article R3 
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Obligations of importers
Article R4 
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Obligations of distributors
Article R5 
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Cases in which obligations of manufacturers apply to importers and distributors
Article R6 
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Identification of economic operators
Article R7 
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Chapter R3
Conformity of the product
Presumption of conformity
Article R8 
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Formal objection to a harmonised standard
Article R9 
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EC declaration of conformity
Article R10 
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General principles of the CE marking
Article R11 
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Rules and conditions for affixing the CE marking
Article R12 
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Chapter R4
Notification of conformity assessment bodies
Notification
Article R13 
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Notifying authorities
Article R14 
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Requirements relating to notifying authorities
Article R15 
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Information obligation on notifying authorities
Article R16 
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Requirements relating to notified bodies
Article R17 
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Presumption of conformity
Article R18 
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Formal objection to a harmonised standard
Article R19 
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Subsidiaries of and subcontracting by notified bodies
Article R20 
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Accredited in-house bodies
Article R21 
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Application for notification
Article R22 
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Notification procedure
Article R23 
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Identification numbers and lists of notified bodies
Article R24 
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Changes to notifications
Article R25 
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Challenge of the competence of notified bodies
Article R26 
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Operational obligations of notified bodies
Article R27 
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Information obligation on notified bodies
Article R28 
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Exchange of experience
Article R29 
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Coordination of notified bodies
Article R30 
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Chapter R5
Safeguard procedures
Procedure for dealing with products presenting a risk at national level
Article R31 
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Community safeguard procedure
Article R32 
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Compliant products which present a risk to health and safety
Article R33 
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Formal non-compliance
Article R34 
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ANNEX II
CONFORMITY ASSESSMENT PROCEDURES
Module A Internal production control 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Technical documentation 

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 3. Manufacturing 

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 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up. 

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 5. Authorised representative 

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Module A1 Internal production control plus supervised product testing 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Technical documentation 

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 3. Manufacturing 

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 4. Product checks 

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 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up. 

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 6. Authorised representative 

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Module A2 Internal production control plus supervised product checks at random intervals 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Technical documentation 

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 3. Manufacturing 

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 4. Product checks 

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 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up. 

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 6. Authorised representative 

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Module B EC-type examination 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. EC-type examination may be carried out in either of the following manners: 

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 3. The manufacturer shall lodge an application for EC-type examination with a single notified body of his choice. 

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 4. The notified body shall: 

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 4.1. examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product; 

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 4.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6. Where the type meets the requirements of the specific legislative instrument that apply to the product concerned, the notified body shall issue an EC-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached. 

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 7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. 

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 8. Each notified body shall inform its notifying authorities concerning the EC-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. 

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 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Module C Conformity to type based on internal production control 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Manufacturing 

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 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. 

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 4. Authorised representative 

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Module C1 Conformity to type based on internal production control plus supervised product testing 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Manufacturing 

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 3. Product checks 

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 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. 

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 5. Authorised representative 

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Module C2 Conformity to type based on internal production control plus supervised product checks at random intervals 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Manufacturing 

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 3. Product checks 

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 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. 

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 5. Authorised representative 

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Module D Conformity to type based on quality assurance of the production process 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Manufacturing 

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 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. 

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 3.2. The quality system shall ensure that the products are in conformity with the type described in the EC-type examination certificate and comply with the requirements of the legislative instrument that apply to them. 

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 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. 

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 3.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. 

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 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: 

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 4.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. 

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 6. The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: 

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 7. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. 

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 8. Authorised representative 

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Module D1 Quality assurance of the production process 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Technical documentation 

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 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. Manufacturing 

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 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. 

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 5.2. The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them. 

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 5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2. 

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 5.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. 

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 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: 

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 6.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. 

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 8. The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: 

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 9. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. 

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 10. Authorised representative 

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Module E Conformity to type based on product quality assurance 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Manufacturing 

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 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. 

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 3.2. The quality system shall ensure compliance of the products with the type described in the EC-type examination certificate and with the applicable requirements of the legislative instrument. 

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 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. 

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 3.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. 

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 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: 

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 4.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. 

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 6. The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: 

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 7. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. 

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 8. Authorised representative 

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Module E1 Quality assurance of final product inspection and testing 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Technical documentation 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. Manufacturing 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.2. The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 8. The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 9. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 10. Authorised representative 

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Module F Conformity to type based on product verification 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Manufacturing 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3. Verification 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.3. If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that have been found not to satisfy the tests. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities, for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 8. Authorised representative 

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Module F1 Conformity based on product verification 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Technical documentation 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3. Manufacturing 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. Verification 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.3. If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that have been found not to satisfy the tests. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 9. Authorised representative 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Module G Conformity based on unit verification 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Technical documentation 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3. Manufacturing 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. Verification 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.2. The manufacturer shall draw up a written declaration of conformity and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6. Authorised representative 

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Module H Conformity based on full quality assurance 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Manufacturing 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.2. The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6. The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 8. Authorised representative 

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Module H1 Conformity based on full quality assurance plus design examination 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Manufacturing 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.2. The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.6. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2. The application shall make it possible to understand the design, manufacture and operation of the product, and to assess the conformity with the requirements of the legislative instrument that apply to it. It shall include: 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.3. The notified body shall examine the application, and where the design meets the requirements of the legislative instrument that apply to the product it shall issue an EC design examination certificate to the manufacturer. The certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. The certificate may have one or more annexes attached. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.4. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.5. Each notified body shall inform its notifying authorities of the EC design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up and shall mention the number of the design examination certificate. 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7. The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 8. Authorised representative 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TABLE: CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION 

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ANNEX III
EC DECLARATION OF CONFORMITY

1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Signed for and on behalf of: …………………………………
(place and date of issue):
(name, function) (signature):
