The European Parliament voted in favor of delaying the implementation of the new Medical Device Regulation (MDR) and approved the European Commission's plan, which was adopted in January. The plan involves extending the deadlines for compliance with the new certification rules for medical devices, with the timeline varying based on the risk class of the device.
This measure aims to guarantee patients' continuous access to medical technologies. The European Commission also stated that devices that were placed on the market under the existing legal framework can still be sold.
Key changes include:
● The transition period to the new rules for medical devices, covered by a certificate or declaration of conformity issued before 26 May 2021, has been extended. Higher risk devices will have until 31 December 2027 to transition, while medium and lower risk devices will have until 31 December 2028. However, the extension will only apply to devices that are safe and for which manufacturers have already taken steps to transition to the new rules provided by the Medical Devices Regulation. Certain conditions will need to be met for the extension to apply.
● The proposal suggests a transition period for class III implantable custom-made devices until 26 May 2026, which will allow their manufacturers more time to obtain certification from a notified body. To benefit from the transition period, the manufacturer must apply for a conformity assessment of such devices before 26 May 2024.
● The proposal extends the validity of certificates that were issued until 26 May 2021, which is the day when the Medical Devices Regulation became applicable. This extension is intended to align with the transition periods proposed by the amendments.
● The Commission's proposal suggests the removal of the 'sell-off' date, which is currently present in both the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation. This date marks the deadline for withdrawing medical devices that are already on the market and available for purchase. The proposed removal of the 'sell-off' date aims to ensure the availability of safe and essential medical devices for healthcare systems and patients in need.