In Article 44 of Regulation (EU) 2017/745, paragraph 10 is replaced by the following:

‘10. 5 years after notification of a notified body, and again every 5 years thereafter, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be conducted by the authority responsible for notified bodies of the Member State in which the body is established and by a joint assessment team in accordance with the procedure described in Article 39.

The authority responsible for notified bodies of the Member State in which the notified body is established may conduct a complete re-assessment prior to the dates referred to in the first subparagraph, upon request by the notified body or where, based on the results of the annual assessments conducted in accordance with paragraph 4 of this Article, it has concerns regarding the continued fulfilment by the notified body of the requirements set out in Annex VII.

Complete re-assessments that have already started prior to 11 March 2023 shall continue to be conducted, unless the authority responsible for notified bodies of the Member State in which the notified body is established decides to suspend or terminate the ongoing complete re-assessment, taking into account its own resources and the resources of the notified body already spent on the re-assessment, as well as the results of the annual assessments conducted in accordance with paragraph 4 of this Article. Before suspending or terminating an ongoing complete re-assessment, the authority responsible for notified bodies shall hear the notified body concerned.’.

COMMISSION DELEGATED REGULATION (EU) 2023/502 of 1 December 2022 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies