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Internal Market, Industry, Entrepreneurship and SMEs

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

  • A product undergoes a conformity assessment before it is placed on the market
  • It needs to demonstrate that it meets all legislative requirements
  • It includes testing, inspection and certification
  • The applicable product legislation specifies the procedure for each product

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 manufacturer carries out the assessment. The conformity assessment process involves a conformity assessment body if required by the applicable legislation – 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

Warning about unregulated certificates

Unregulated certificates, which are often called ‘voluntary certificates’ besides other names, are often issued for some products covered by EU harmonisation legislation by certification bodies not acting in their capacity as notified bodies under EU law. These practices are misleading, since only notified bodies may issue certificates of compliance for harmonised products and only in the area for which they are notified. For example, if a body is notified for issuing certificates for machinery, it should not issue certificates (voluntary or other) for non-machinery products (such as personal protective equipment – masks).

Please note that, under EU law, voluntary or other additional certificates are not a recognised means to prove compliance. Consequently, they have no value in case of checks by market surveillance authorities or customs. However, an exception arises in instances where voluntary certification is outlined in specific legislation. In such cases, while the certificate is not obligatory, it must adhere to explicit requirements if chosen to be acquired.

Voluntary certificates can create the impression that the product conforms with applicable EU harmonisation legislation, although such certificates are not issued by an authorised body.

Voluntary certificates must not be confused with third party conformity assessment certification by notified bodies within the area for of competence for which they are notified, due to the use of terms such as ‘certification’ or ‘independent third party’ or the presence of the CE marking on the certificate.

CE marking can only be affixed after testing the product and performing the conformity assessment procedure prescribed by the applicable EU harmonisation legislation. It is not acceptable for voluntary certificates to bear a CE marking.

More information

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.