14.03.2023
To the attention of manufacturers of medical devices, in vitro diagnostic medical devices, authorised representatives, economic operators and all stakeholders
Please be informed that, on 08.03.2023, the European Commission has published the 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 and Commission Delegated Regulation (EU) 2023/503 of 1 December 2022 amending Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies, changing the deadlines for re-assessment of notified bodies from 3 to 5 years and setting the frequency of their subsequent complete re-assessment every 5 years.
These Regulations are available here:
Directives and regulations – Medical Devices