A manufacturer can only place a product on the EU market when it meets all the applicable requirements. The conformity assessment procedure is carried out before the product can be sold. The European Commission’s main objective is to help ensure that unsafe or otherwise non-compliant products do not find their way to the EU market.
What conformity assessment is
- The conformity of a product is assessed before it is placed on the market.
- It needs to demonstrate that all legislative requirements are met.
- It includes testing, inspection and certification.
- The procedure for each product is specified in the applicable product legislation.
Objectives of the conformity assessment procedure
- To demonstrate that a product being placed on the market complies with all legislative requirements.
- The procedure should ensure confidence of consumers, public authorities and manufacturers regarding the conformity of products.
How does it work in practice?
- Product legislation describes the conformity assessment procedures for each product.
- Manufacturers may choose between different conformity assessment procedures, if applicable.
- The assessment is carried out by the manufacturer. If the applicable legislation requires it, a conformity assessment body is involved in the conformity assessment process – see Notified bodies.
Conformity assessment is complementary to market surveillance. Both procedures help ensure the smooth functioning of the internal market.
Declaration of Conformity
As part of conformity assessment, the manufacturer or the authorised representative must draw up an Declaration of conformity (DoC). The declaration should contain all information to identify:
- the product
- the legislation according to which it is issued
- the manufacturer or the authorised representative
- the notified body if applicable
- a reference to harmonised standards or other normative documents, where appropriate.
The so-called Blue Guide (2 MB), contains guidance on the application of all aspects of the implementation of EU products rules, including conformity assessments.