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)

Article 4 Conformity assessment procedures

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.