2010/713/EU: 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

The modules for procedures for assessment of conformity and suitability for use of the interoperability constituents and for EC verification of subsystems, as set out in Annex I, are hereby adopted. A list of terms used in the conformity assessment modules specific for railways and their equivalent in generic modules defined in Decision No 768/2008/EC is set out in Annex II. A correlation table of the modules used is attached in Annex III.

The modules shall be applicable to all TSIs which enter in force on or after the date referred to in Article 8.

For the purposes of this Decision, the following definitions shall apply: 1. ‘technical specification for interoperability’ (TSI) means a specification adopted in accordance with Directive 2008/57/EC by which each subsystem or part subsystem is covered in order to meet the essential requirements and ensure the interoperability of the rail system; 2. ‘vehicle’ means a railway vehicle that runs on its own wheels on railway lines, with or without traction. A vehicle is composed of one or more structural and functional subsystems or parts of such subsystems; 3. ‘subsystems’ means the result of the division of the rail system, as shown in Annex II to Directive 2008/57/EC; 4. ‘interoperability constituents’ means any elementary component, group of components, sub-assembly or complete assembly of equipment incorporated or intended to be incorporated into a subsystem, upon which the interoperability of the rail system depends directly or indirectly. The concept of a ‘constituent’ covers both tangible objects and intangible objects such as software; 5. ‘applicant’ means contracting entity or manufacturer; 6. ‘contracting entity’ means any entity, whether public or private, which orders the design and/or construction or the renewal or upgrading of a subsystem. This entity may be a railway undertaking, an infrastructure manager or a keeper, or the concession holder responsible for carrying out a project; 7. ‘notified bodies’ means the bodies which are responsible for assessing the conformity or suitability for use of the interoperability constituents or for appraising the ‘EC’ procedure for verification of the subsystems; 8. ‘harmonised standard’ means any European standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services in connection with a mandate by the Commission drawn up in accordance with the procedure referred to in Article 6(3) of that Directive, which, by itself or together with other standards, provides a solution as regards compliance with a legal provision; 9. ‘placing in service’ means all the operations by which a subsystem or a vehicle is put into its design operating state; 10. ‘placing on the market’ means the first making available of an interoperability constituent on the Union market; 11. ‘manufacturer’ means 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; 12. ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer or a contracting entity to act on their behalf in relation to specified tasks; 13. ‘conformity assessment’ means the process demonstrating whether requirements specified in the relevant TSI relating to an interoperability constituent have been fulfilled; 14. ‘assessment of suitability for use’ means the process demonstrating whether requirements for suitability for use specified in the relevant TSI relating to an interoperability constituent have been fulfilled; 15. ‘EC verification’ means the procedure referred to in Article 18 of Directive 2008/57/EC whereby a notified body checks and certifies that the subsystem complies with Directive 2008/57/EC, relevant TSI(s) and with the other regulations deriving from the Treaty, and may be put into operation.

1 The procedures for conformity assessment for the interoperability constituents covered by the TSIs shall be chosen among the modules set out in Annex I, in accordance with the following criteria: (a) whether the module concerned is appropriate to the type of interoperability constituent; (b) the nature of the risks entailed by the interoperability constituent and the extent to which conformity assessment corresponds to the type and degree of risk; (c) the need for the manufacturer to have a choice between quality management system and product certification modules set out in Annex I; (d) the need to avoid imposing modules which would be too burdensome in relation to the risks.

2 The TSI(s) shall specify the modules for conformity assessment to be applied for the interoperability constituents. Where necessary, the TSI(s) may clarify and complement them due to the specificity of the sub system concerned.

Where the TSIs so require, the procedure for assessment of suitability for use of the interoperability constituents shall be done in accordance with the instructions set out in the module CV set out in Annex I.

1 The EC verification procedures for the subsystems covered by the TSIs shall be chosen among the modules set out in Annex I, in accordance with the following criteria: (a) whether the module concerned is appropriate to the type of the subsystem; (b) the nature of the risks entailed by the subsystem and the extent to which EC verification corresponds to the type and degree of risk; (c) the need for the manufacturer to have a choice between quality management system and product certification modules set out in Annex I; (d) the need to avoid imposing modules which would be too burdensome in relation to the risks.

2 The TSI(s) shall specify the modules for EC verification to be applied for the subsystems. Where necessary, the TSI(s) may clarify and complement them due to the specificity of the sub system concerned.

1 Where a notified body subcontracts specific tasks connected with conformity assessment or EC verification or has recourse to a subsidiary, it shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

2 Activities may be subcontracted or carried out by a subsidiary only with the agreement of the applicant.

This Decision shall apply from 1 January 2011.

This Decision is addressed to the Member States.