# 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) EU Decision 2008/768 · adopted 9 July 2008 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) ## Introductory text 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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 1 General principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Subject matter and scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Level of protection of public interests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Conformity assessment procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 EC declaration of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Conformity assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Reference provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Repeal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex I: REFERENCE PROVISIONS FOR COMMUNITY HARMONISATION LEGISLATION FOR PRODUCTS ### Chapter R1: Definitions ## R1 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Chapter R2: Obligations of economic operators ## R2 Obligations of manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R3 Authorised representatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R4 Obligations of importers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R5 Obligations of distributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R6 Cases in which obligations of manufacturers apply to importers and distributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R7 Identification of economic operators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Chapter R3: Conformity of the product ## R8 Presumption of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R9 Formal objection to a harmonised standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R10 EC declaration of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R11 General principles of the CE marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R12 Rules and conditions for affixing the CE marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Chapter R4: Notification of conformity assessment bodies ## R13 Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R14 Notifying authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R15 Requirements relating to notifying authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R16 Information obligation on notifying authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R17 Requirements relating to notified bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R18 Presumption of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R19 Formal objection to a harmonised standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R20 Subsidiaries of and subcontracting by notified bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R21 Accredited in-house bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R22 Application for notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R23 Notification procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R24 Identification numbers and lists of notified bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R25 Changes to notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R26 Challenge of the competence of notified bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R27 Operational obligations of notified bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R28 Information obligation on notified bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R29 Exchange of experience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R30 Coordination of notified bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Chapter R5: Safeguard procedures ## R31 Procedure for dealing with products presenting a risk at national level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R32 Community safeguard procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R33 Compliant products which present a risk to health and safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## R34 Formal non-compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex II: CONFORMITY ASSESSMENT PROCEDURES ### Division Module A: Internal production control ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Technical documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Authorised representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division Module A1: Internal production control plus supervised product testing ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Technical documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Product checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Authorised representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division Module A2: Internal production control plus supervised product checks at random intervals ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Technical documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Product checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Authorised representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division Module B: EC-type examination ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 EC-type examination may be carried out in either of the following manners: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 The manufacturer shall lodge an application for EC-type examination with a single notified body of his choice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 The notified body shall: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4.1 examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product; . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division Module C: Conformity to type based on internal production control ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Authorised representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division Module C1: Conformity to type based on internal production control plus supervised product testing ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Product checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Authorised representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division Module C2: Conformity to type based on internal production control plus supervised product checks at random intervals ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Product checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Authorised representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division Module D: Conformity to type based on quality assurance of the production process ## 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 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division Module D1: Quality assurance of the production process ## 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division Module E: Conformity to type based on product 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 type described in the EC-type examination certificate and with the applicable requirements of the legislative instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Division 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex III EC DECLARATION OF CONFORMITY Signed for and on behalf of: ………………………………… (place and date of issue): (name, function) (signature): ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . --- Source: https://www.legislation.gov.uk/eudn/2008/768 (the official version) Page: https://openlegislation.uk/eu-decision-2008-768 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.