Conformity assessment
Two of the most important elements of the New Legislative Framework (NLF) are:
- the essential requirements governing the characteristics of the products covered;
- the conformity assessment procedures required to demonstrate that a product, before it is placed on the market, conforms to these essential requirements of the directive that apply to it.
Conformity assessment must not be confused with market surveillance, which consists of controls after the product has been placed on the market. However both techniques are complementary and equally necessary to ensure the smooth functioning of the internal market.
In the context of New Legislative Framework, the assessment of the conformity of a product is carried out before this product is placed on the market and consists in demonstrating that it fulfils all the legislative requirements that apply to it. The essential objective of a conformity assessment procedure is to demonstrate public authorities that products placed on the market conforms to the requirements as expressed in the provisions of the relevant legislation, in particular with regard to the health and safety of users and consumers.
Conformity assessment is performed following technical procedures which are specified in the sectoral legislation. Conformity assessment procedures are composed of one or two conformity assessment modules. A conformity assessment procedure covers both design and production phases; while a module may cover either one of these two phases (when a conformity assessment procedure is composed of two modules) or both (in this case a conformity assessment procedure is composed of one module).
All procedures/modules are set out in the NLF and serve for the sectoral legislator as a simple, coherent and complete menu to select the most appropriate module(s)/procedure(s) for the specific area of activity.
The assessment of the conformity of the product in question may be carried out either by the manufacturer himself or by a (manufacturer's in-house or external) conformity assessment body, depending on the provisions of the modules selected by the relevant sectoral legislative instrument.
It is the responsibility of the Member States to notify those external conformity assessment bodies within their jurisdiction that are technically competent to assess the compliance of products with the requirements of the directives(s) that apply to them. In-house bodies do not need to be notified but they have still to demonstrate the same technical competence as external bodies. Member States must also ensure that the (in-house or external) bodies permanently maintain their technical competence.
Conformity assessment procedures
As already stated, conformity assessment procedures are equivalent from a legal point of view but not technically identical in terms of methods. However, their application in practice is such that the result is sufficient confidence on all sides as regards the conformity of products to the relevant essential requirements
As a general rule a product should be covered by conformity assessment both during the design and production phase. The directives specify the combination of modules, i.e. conformity assessment procedures, that cover both design and production phase and are available to the manufacturer to demonstrate conformity.
Several modules have their variants. The reason for providing variants within modules (this applies for all variants of all modules of NLF) is to enable that for products presenting higher level of risk the necessary level of protection is ensured, whilst avoiding impose a more complicated module. Should these variants not exist, the legislator would have to opt for a procedure that is more burdensome for the manufacturers.
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