32008R0765

WHAT IS THE AIM OF THE REGULATION?

• It lays common rules for accreditation of conformity assessment bodies in the European Union (EU).
• It also establishes the general principles for CE marking¹.

KEY POINTS

National accreditation bodies

• EU Member States must:
  • appoint a single not-for-profit national accreditation organisation;
  • ensure the organisation has sufficient financing and staff to carry out its duties;
  • monitor the organisation to ensure it fulfils the requirements set;
  • communicate the relevant details to the European Commission, which draws up a publicly available list of the various national organisations.
• National accreditation bodies must:
  • determine whether individual conformity assessment organisations² are competent to do their work and monitor their performance;
  • restrict, suspend or withdraw the accreditation certificates of assessment organisations that become unable to carry out their duties;
  • be objective and impartial with efficient management and appropriate internal controls in place;
  • agree to peer evaluation;
  • inform other national accreditation bodies of their conformity assessment activities;
  • make information on their work publicly available.
• The association European co-operation for Accreditation manages the peer evaluations to ensure the quality of the services the national accreditation bodies provide.
• CE marking may only be attached to a product by a manufacturer or someone mandated to operate on their behalf, provided it satisfies all the conformity standards.
• Amending Regulation (EU) 2019/1020 removes the articles in Regulation (EC) No 765/2008 that previously dealt with market surveillance aspects (see summary).

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 1 January 2010.

BACKGROUND

• Accreditation is part of an overall system that includes conformity assessment and market surveillance.
• For more information, see:
  • Accreditation of conformity assessment bodies (European Commission).

KEY TERMS

1. CE marking. A marking manufacturers use to indicate the item meets EU legal conformity standards.
2. Conformity assessment body. A body that performs activities such as calibration, testing, certification and inspection.

MAIN DOCUMENT

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, pp. 30–47).

Successive amendments to Regulation (EC) No 765/2008 have been incorporated in the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, pp. 1–18).

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82–128).

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, pp. 4–17).

See consolidated version.