art_11__para_8__text_1

The Commission shall adopt delegated acts in accordance with Article 21, in order to supplement this Directive, by determining the appropriate conformity assessment procedure applicable to products covered by this Article on the basis of the modules in Annex II to Decision No 768/2008/EC of the European Parliament and of the Council 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 (OJ L 218, 13.8.2008, p. 82). . In determining which conformity assessment procedure is to be used, the Commission shall ensure that the objectives referred to in Article 1(2) of this Directive are complied with, whilst taking into account the principle of proportionality. For this purpose, the Commission shall take as a starting point the System 1+ of assessment and verification of constancy of performance set out in Annex V to Regulation (EU) No 305/2011, or a broadly equivalent procedure, except where it would be disproportionate. The delegated acts referred to in this paragraph shall also contain rules for the designation of conformity assessment bodies, where such are involved in the respective conformity assessment procedures.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-28 · Text as adopted (Official Journal); later amendments are not incorporated in this text.