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Frequency of complete re-assessments of notified bodies under MDR extended

  • Posted by: inetika
  • Category: GLOBAL NEWS

Commission Delegated Regulation (EU) 2023/502 of 1 December 2022, which took on 11 March 2023, reduces the frequency of complete re-assessments of notified bodies from three years (1st complete re-assessment) and four years (following the 1st) to every 5 years in both cases; however, the competent authorities have the liberty to decide if complete re-assessment may be done sooner.

Article 1 of 2023/502 states that paragraph 10 of MDR Article 44 is replaced with new wording, the first paragraph of which will now state:

“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.”

Copies of Regulation 2023/502 can be accessed from here.