Since 2017, the regulatory requirements for all medical devices have been strengthened to ensure optimal end-user and patient safety, as well as the proper functioning of the internal market for DMs. Now, conformity assessment of DMs is more complex to ensure the quality and performance of devices.
At the start of this year, the European Parliament and Council have just proposed a staggered extension of the transitional period. Thus, the transition period provided for by the regulation, which was supposed to end on May 26, 2024, would be extended by an additional “end-of-sale” provision. This would allow the availability of medical devices in the supply chain until May 2025. For high-risk in-vitro diagnostic medical devices, the transitional periods would be extended to May 26, 2025, and to May 26, 2027 for low-risk in-vitro diagnostic devices. Finally, devices manufactured and used in healthcare facilities could go until May 26, 2028.
The application of the regulation implies the implementation of numerous tools, in particular concerning the traceability of MD, and a final assessment of conformity by a notified body. But there are not enough bodies in Europe, and many manufacturers are still waiting for an evaluation to obtain the certification that will allow the marketing of their DM. In this context, the risk of shortages or disruptions in the supply chain would inevitably increase and threaten healthcare systems and patients. This is a fact that fully justifies the extension of the transitional period that should be voted on soon!
What are the applicable transitional periods?
The length of the proposed conditional extension of the transition periods depends on the type of device. For example, a shorter transition period is provided for higher risk devices such as implants (until December 2027). But longer periods for medium and lower risk devices such as syringes or reusable surgical instruments will apply (until December 2028).
Is the application of the regulation postponed?
Absolutely not! The Medical Device Regulation is and remains applicable as of May 26, 2021. The proposed targeted amendment does not substantively change any requirements of the medical device regulation. It merely amends the transitional provisions to allow manufacturers and notified bodies additional time to transition from the previously applicable rules to the requirements of the Regulation, subject to specific conditions.
Which products will benefit from the extension?
The conditional extension only applies to medical devices, such as pacemakers or syringes, that are already covered by the transition period. This means that the extended transition period only applies to “old devices”, i.e. those covered by a certificate or declaration of conformity issued under Council Directives 90/385/EEC or 93/42/EEC before 26 May 2021.
In addition, the application of the extended transition period will be subject to several cumulative conditions to ensure that only devices that are safe and for which manufacturers have already taken steps to transition to the medical device regulation will be granted additional time.
In addition, the Commission proposes to introduce a transitional period until May 26, 2026 also for Class III custom-made implantable devices, such as patient-specific implants for bone reconstruction. These devices are currently not covered by the transitional provisions of the regulation.
While manufacturers of Class III custom-made implantable devices are required to comply with all the requirements of the applicable regulation as of May 26, 2021, they will now have more time to obtain certification of their quality management system by a notified body. Also in this case, the transition period only applies if the manufacturer has submitted an application before May 26, 2024 that has resulted in a contract with the notified body before September 26, 2024.