§5.3.2.4 Article 5(2) of Regulation (EC) No 765/2008

According to Article 5(2) of Regulation (EC) No 765/2008, when a Member State does not base its notification on 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 Union harmonisation legislation in question’ (263). In order to ensure the necessary level of confidence in the impartiality and technical competence of conformity assessment bodies and in the reports and certificates issued by them, national authorities, when carrying out the assessment without accreditation, should give detailed and comprehensive information describing how the candidate Notified Body has been assessed as qualified to carry out the tasks for which it is notified and showing that it fulfils the applicable criteria relating to notified bodies. This information, linked to a given notification, is made available to the Commission and the other Member States using the NANDO electronic notification tool. The evaluation procedure should be based on at least the following elements: — a formal application procedure — assessment against applicable requirements. — production of an assessment report — clear decision-making process — existence of a systematic surveillance and related sanction mechanism, providing for periodic surveillance including on-site visits, in order to verify the continued fulfilment of requirements by the notified body — demonstration of the national authority’s own technical competence for assessing conformity assessment bodies for the purpose of notification under technical harmonisation legislation. This demonstration must give equivalent assurance as the EA (264) peer evaluation system. — the candidate notified bodies should be made aware of general conditions, of their rights and obligations, and of the requirements relating to assessment carried out with a view to notification The assessment itself should consist of: — a review of documents verifying the completeness and appropriateness from a substantial point of view with regard to conformity to the applicable requirements — an on-site audit to check technical and procedural aspects - such as the availability and appropriateness of facilities and equipment, the technical competence of staff, the existence of an appropriate management system - and to check other aspects demonstrating that conformity to requirements is properly implemented. The assessment must include witnessing technical activities. When choosing an assessment process other than formal accreditation, notifying authorities must indicate the reasons why accreditation is not chosen to back up the notification process. Moreover, notifying authorities may not outsource to the national accreditation body the assessment of unaccredited conformity assessment bodies that seek to become notified bodies, without fulfilling the whole accreditation process including the delivery of the accreditation certificate. When accreditation is not used, the notifying authorities must perform periodical verifications to ensure the continuous competence of the notified body, in the same way as national accreditation bodies do.

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