# Commission Decision of 9 November 2010 on modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council (notified under document C(2010) 7582) (Text with EEA relevance) (2010/713/EU) (revoked) EU Decision 2010/713 ยท adopted 9 November 2010 Commission Decision of 9 November 2010 on modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council (notified under document C(2010) 7582) (Text with EEA relevance) (2010/713/EU) ## Introductory text Commission Decision of 9 November 2010 on modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council (notified under document C(2010) 7582) (Text with EEA relevance) (2010/713/EU) (revoked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 1 Subject matter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Conformity assessment procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Procedure for assessment of suitability for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 EC verification procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Subsidiaries of and subcontracting by notified bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Addressees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex I: Modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability ## MODULES FOR CONFORMITY ASSESSMENT OF INTEROPERABILITY CONSTITUENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Module CA Internal production control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Technical documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 EC declaration of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4.1 The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it together with the technical documentation at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured. The EC declaration of conformity shall identify the interoperability constituent for which it has been drawn up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Authorised representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## MODULES FOR SUITABILITY FOR USE OF INTEROPERABILITY CONSTITUENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Module CV Type validation by in-service experience (suitability for use) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Type validation by in-service experience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 EC declaration of suitability for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11.1 The manufacturer shall draw up a written EC declaration of suitability for use for an interoperability constituent and keep it at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured. The EC declaration of suitability for use shall identify the interoperability constituent for which it has been drawn up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11.2 The EC declaration of suitability for use shall meet the requirements of Article 13(3) and point 3 of Annex IV to Directive 2008/57/EC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11.3 The interoperability constituent may be placed on the market only after the following EC declarations have been drawn up: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Authorised representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## MODULES FOR EC VERIFICATION OF SUBSYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Module SB EC-type examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 EC-type examination shall be carried out by: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 The applicant shall lodge an application for EC-type examination with a notified body of his choice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 The notified body shall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 When the subsystem referred to in point 3 is subject to derogation(s) procedure according to Article 9 of Directive 2008/57/EC, the applicant shall inform the notified body thereof. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Where the type meets the requirements of the relevant TSI(s) that apply to the subsystem concerned, the notified body shall issue an EC-type examination certificate to the applicant. The certificate shall contain the name and address of the applicant, 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . --- Source: https://www.legislation.gov.uk/eudn/2010/713 (the official version) Page: https://openlegislation.uk/eu-decision-2010-713 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.