Accreditation is a must have for an EU Notified Body?

Let us see what the 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 (Text with EEA relevance) says about:

(12) Where Community harmonisation legislation provides for the selection of conformity assessment bodies for its implementation, transparent accreditation, as provided for in this Regulation, ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Community the preferred means of demonstrating the technical competence of those bodies. However, national authorities may consider that they possess the appropriate means of carrying out this evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.

Article 5

Operation of accreditation

1. A national accreditation body shall, when requested by a conformity assessment body, evaluate whether that conformity assessment body is competent to carry out a specific conformity assessment activity. Where it is found to be competent, the national accreditation body shall issue an accreditation certificate to that effect.

2. When a Member State decides not to use accreditation, it shall provide the Commission and the other Member States with all the documentary evidence necessary for the verification of the competence of the conformity assessment bodies it selects for the implementation of the Community harmonisation legislation in question.

Link to regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008R0765&from=HU

DECISIONS ADOPTED JOINTLY BY THE EUROPEAN PARLIAMENT AND THE COUNCIL 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 (Text with EEA relevance) says:

(40) If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be presumed to comply with the corresponding requirements set out in the relevant sectoral legislation.

(41) Where Community harmonisation legislation provides for the selection of conformity assessment bodies for its implementation, transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Community the preferred means of demonstrating the technical competence of those bodies. However, national authorities may consider that they possess the appropriate means of carrying out this evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demon- strating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.

Link to regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008D0768&from=HU

Based on all accreditation is not a must have but preferred.

If there is no accreditation, but there is proof of evidence and accepted by all EU member states an ATEX Notified Body can operate without accreditation.

The same procedures shall be followed and tracked in all cases – same legislative framework applies. Regarding the value of issued certificates there shall be no difference.

It is legal, and correct.

Keep up good work.

Arpad
exprofessional.com

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