§5.1.2 The modular structure of conformity assessment in Union harmonisation legislation

— In Union harmonisation legislation, conformity assessment procedures cover both design and production phases. They are composed of one or two modules. Some modules cover both phases. In other cases, distinct modules are used for each phase. — Decision No 768/2008/EC lays down the ‘horizontal menu’ of conformity assessment modules and the ways procedures are built of modules. — The legislator selects from the menu of conformity assessment modules/procedures (laid down under Decision No 768/2008/ EC) the most appropriate ones for the concerned sector. Under Union harmonisation legislation, conformity assessment procedures are composed of one or two conformity assessment modules. As products are subjected to conformity assessment both during the design and production phase, a conformity assessment procedure covers both design and production phases; while a module may cover: — either one of these two phases (in this case a conformity assessment procedure is composed of two modules); — or both (in this case a conformity assessment procedure is composed of one module). Decision No 768/2008/EC, lays down a ‘horizontal menu’ of conformity assessment modules and the ways procedures are built of modules. The legislator selects from the menu of conformity assessment modules/procedures (laid down under Decision No 768/2008/EC) the most appropriate one(s) in order to address the specific needs of the concerned sector (242). The least onerous modules should be selected taking into account the type of products and hazards involved, the impact on the protection of public interests, the economic infrastructure of the given sector, the methods of production etc. Where possible a choice of inspection, certification, and/or quality assurance modules should be provided. Conformity assessment procedures are equivalent from a legal point of view but not technically identical in terms of methods. Their application in the sectoral legislation aims at providing high level of confidence as regards the conformity of products to the relevant essential requirements. The intention of the modules as laid down in the Decision No 768/2008/EC is to allow for a limited number of possible procedures. Nevertheless, the choice offered needs to be sufficiently varied in order to be applicable to the widest range of products concerned. Union harmonisation legislation establishes conformity assessment procedures by either leaving the manufacturer no choice or by establishing a range of procedures from which the manufacturer must choose. As conformity assessment procedures in Union harmonisation legislation originate from Decision No 768/2008/EC, they remain consistent and coherent. Thus the assessment of product conformity becomes more transparent especially in cases where more than one harmonisation legislative act applies to a product.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07