The deadline for the certification of certain medical devices extended
Manufacturers of medical devices can now for a while breathe a sigh of relief. The European Parliament have finally adopted a proposal for extending the certification deadlines as stipulated in the Medical Device Regulation ("the MDR").
On 16th February 2023 the European Parliament adopted a proposal on extending the deadlines for the certification of certain medical devices as established in the MDR.
The risk class of the medical device decides the length of the granted deadline extension. For instance, higher risk medical devices are granted the shortest extension.
The new deadlines are as follows:
- For medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.
- A transition period until 26 May 2026 is introduced for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before 26 May 2024.
- The "sell-off" date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation is removed. The "sell-off" date was the end date after which devices that have already been placed on the market should be withdrawn. Removing this "sell-off" date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need.
Next step is publication of the adopted text in the Official Journal of the European Union and then the new deadlines become applicable on the same day.
Would you like to know more?
If you would like to know more about the rules on medical devices and in vitro diagnostic medical devices, please contact Plesner's Life science Team.
Read the text adopted by the European Parliament 16th February 2023