Implications of the Extended Transition Period and How it Impacts Legacy Devices and Their Marketing Authorization
The evolution of the regulatory landscape in the medical devices sector has witnessed a notable transition from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR 2017/745). With the MDR becoming effective from May 26, 2021, an important consideration in this shift is the transition process for legacy devices and their market authorization conditions.
Understanding the Extended Transition Period
The MDR provides a transitional period allowing economic operators to market medical devices that have compliance certificates under MDD until May 26, 2024. However, due to concerns about insufficient evaluation capacity of notified bodies and potential reduction of product portfolios at the end of the transition period, the European Commission adopted an amendment to the MDR on January 13, 2023, extending the transition period for devices already covered by the transition.
This extension is segregated as follows, based on certificates or declarations of conformity issued before May 26, 2021:
- Until December 31, 2027 for high-risk medical devices: Class III devices and Class IIb implantable medical devices, excluding certain dental and surgical devices.
- Until December 31, 2028 for medium and low-risk medical devices: some Class IIb devices, Class IIa devices, and Class I devices marketed in a sterile condition or with a measuring function.
Conditions for the Extended Transition Period
The application of this extended transition period is subject to multiple cumulative conditions outlined in the proposed amendment:
- Devices must comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable.
- Devices must not undergo significant changes in design or intended purpose.
- Devices should not pose an unacceptable risk to the health or safety of patients, users, or others, or to other aspects of public health protection.
- The manufacturer must have implemented a quality management system in line with the MDR by May 26, 2024.
- The manufacturer, or a representative, must have filed a request for device conformity assessment by May 26, 2024.
- The manufacturer and the notified body must have signed a written agreement by September 26, 2024.
Moreover, the MDR requirements related to post-marketing surveillance, market surveillance, vigilance, registration of economic operators, and devices apply to these devices.
Special Transition Period for Class III Custom-made Implantable Devices
The Commission also proposed a transition period for Class III custom-made implantable devices, which could then be marketed or put into service until May 26, 2026, without a certificate issued by a notified body, provided that:
- The manufacturer, or his representative, has filed a request for device conformity assessment by May 26, 2024, and;
- He has signed an agreement with a notified body by September 26, 2024.
End of Sale Date and Next Steps
Notably, the text also eliminates the « end of sale » date currently set in the MDR and the In Vitro Diagnostic Medical Devices Regulation EU 2017/746 (IVDR). This date is the one after which devices that have already been marketed and remain available for purchase should be withdrawn.
The amending regulation must now be adopted by the European Parliament and Council. It is also important to note that the European Commission has initiated a consultation regarding the extension of this transition period from January 11 to 18, 2023.
In conclusion, this extension and the subsequent conditions help to ensure a smooth transition from MDD to MDR, with consideration for the complex challenges associated with bringing legacy