§5.1.1 What is a conformity assessment?

— Conformity assessment is the process carried out by the manufacturer of demonstrating whether specified requirements relating to a product have been fulfilled. — A product is subjected to conformity assessment both during the design and production phase. Two important elements of every legislative act covering products are: — the legislative requirements governing the characteristics of the products covered; — and the conformity assessment procedures the manufacturer carries out in order to demonstrate that a product, before it is placed on the market, conforms to these legislative requirements. This guide addresses conformity assessment as this is laid down under Decision No 768/2008/EC (particularly for the Union harmonisation legislation under the ‘New Approach’ and now the New Legislative Framework). A product is subjected to conformity assessment both during the design and production phase. Conformity assessment is the responsibility of the manufacturer. Should a manufacturer subcontract design or production, he still remains responsible for the execution of conformity assessment. Conformity assessment must not be confused with market surveillance, which consists of controls by the national market surveillance authorities after the product has been placed on the market. However both techniques are complementary and equally necessary to ensure the protection of the public interests at stake and the smooth functioning of the internal market. The essential objective of a conformity assessment procedure is to demonstrate that products placed on the market conform to the requirements expressed in the provisions of the relevant legislation.

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