The Commission of the European Union (EU) has proposed extending the transition period for existing medical devices under its Medical Device Regulation (EU 2017/745, also known as the MDR) and the In Vitro Diagnostic Regulation (EU 2017/746, also known as the IVDR).
The Commission is seeking to extend the validity of certificates issued between May 2017 and May 2021 under Directive 93/42/EEC for medical devices, Directive 90/385/EEC for active implantable medical devices, and Directive 98/79/EC for in vitro medical devices. According to the formal proposal issued in January, the Commission is proposing extending certificate validity for devices that have been placed on the market until the end of December 2027 for Class III and certain Class IIb implantable devices, and December 2028 for other Class IIb devices and for Class IIa and Class I devices.
The current transition deadline under the MDR is the end of May 2024, while the IVDR’s transition deadlines range from May 2025 to May 2027, depending on the class of the device.
The Commission’s proposed transition deadline extension is an effort to address the shortage of Notified Bodied authorized to qualify devices under the MDR and IVDR, leading to longer-than-anticipated wait times. According to the Commission, other factors, including the Covid Pandemic and the war in Ukraine, have constrained efforts to certify new devices and recertify legacy devices.
Read the text of the EU Commission’s proposal to amend the transitional dates of the MDR and IVDR.
