EU MDR Transition Period Extension
EU MDR Transition Period Extension
On May 26, 2021, the Medical Device Regulation (MDR 2017/745) became effective. The transitional period for CE certifications issued under the Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC) was about to end by May 26, 2024. Despite the steady increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/745, the overall capacity of notified bodies is still not sufficient to ensure the conformity assessment of the large number of devices covered by certificates issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC before 26 May 2024.
This Whitepaper is focused on:
- Reasons for transition period extension
- European Commission’s proposed amendment
- Transition timeline of Class IIa and Clas IIb devices
- Conditions to met in order for the prolonged transition period to take effect
