§5.3.2.2 Assessment of conformity assessment bodies

The assessment of a conformity assessment body seeking notification determines if it is technically competent and capable of carrying out the conformity assessment procedures in question, and if it can demonstrate the necessary level of independence, impartiality and integrity. Member States take the final responsibility for the competence of their notified bodies with respect to the other Member States and the EU institutions. They must therefore verify the competence of the bodies seeking notification, based on the criteria laid down in the applicable Union harmonisation legislation in conjunction with essential requirements and the conformity assessment procedure(s) in question. In general, the competence criteria set out in the Union harmonisation acts cover: — availability of personnel and equipment; — independence and impartiality in relation to those directly or indirectly concerned with the product (such as the designer, the manufacturer, the manufacturer’s authorised representative, the supplier, the assembler, the installer, the user); — technical competence of personnel that is relevant to the products and conformity assessment procedure in question; — maintenance of professional secrecy and integrity; and — subscription to civil liability insurance, unless that liability is covered by the state under national law. Notifying authorities or accreditation bodies must carry out periodic monitoring to assess the continuity of the competence of notified bodies after they are notified. Notified Bodies may have activities or personnel outside the Member State where they are legally established, or even outside the Union. However, the notifying authority of this Member State must be capable of ensuring the monitoring of the whole Notified Body (not only the head office). Having all the testing facilities in another Member State or even outside the EU would make it almost impossible for the notifying authority to monitor the operations of the whole Notified Body. The supervision of multi-site conformity assessment bodies is done under the cross-border cooperation among the national accreditation bodies and notifying authorities; however, the responsibility remains with the notifying authority of the Member State in which the conformity assessment body is established. The conformity assessment body as the main entity to be notified must have itself the means and the competence to carry out the tasks required for the notification. While it may have recourse to subsidiaries/subcontracting, it should not rely for all test and evaluations on subsidiaries/subcontractors (260). The notified body may subcontract specific tasks connected with the conformity assessment, has to ensure that the subcontractor meets the same requirements that are applicable to the notified body itself and may subcontract specific activities only with the agreement of the client. Thus, structures where the head office of the candidate-notified body in the Member State of notification consists of very few staff performing only commercial tasks but none of the conformity assessment tasks for which the body is (to be) notified would be carried out in that Member State, cannot be accepted.

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