The amendment to the Medical Device Regulation 2017/745 (MDR) and the In Vitro Medical Device Regulation 2017/746 (IVDR) has been published and enters into force immediately (20 March 2023). What does this mean for your organisation? The amendment extends transitional periods under the MDR for legacy devices (if manufacturers act now) and removes the “sell-off” date under the MDR and IVDR.
We’ve set out our top four takeaways below:
1. New extended transitional periods: The amendment will allow certain medical devices that are certified under Medical Device Directive and the Active Implantable Medical Device Directive (Directives) prior to 26 May 2021 – called “legacy” devices – to be placed on the EU market or put into service until:
- 31 December 2027 for Class III and Class IIb implantable devices (with some exceptions, such as sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors).
- 31 December 2028 for Class IIb devices other than those referred to above, Class IIa and Class I devices.
2. Conditions for extension of legacy status: The extension will be subject to certain conditions, so that only legacy devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the MDR will benefit from the additional time. This means that the manufacturer must have begun the conformity assessment procedure (by lodging an application for MDR certification with a notified body and there is a signed agreement with the notified body) and implemented a quality management system by 26 May 2024 (notified bodies will conduct surveillance audits).
3. Transition period for class III implantables: The transition period for these is extended until 26 May 2026, giving 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.
4. Removal of the “sell-off” provision in the MDR and in the IVDR: This is the deadline after which devices already on the market (but have not reached the end user) must be withdrawn. With the amendment, devices will not need to be recalled or discarded by this date. 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.