The EU Parliament has adopted the MDR amendment proposal, February 16th, and removed the sell-off date for both medical devices and in-vitro medical devices. The amendment will come in force upon publication in the official journal, which is expected in the coming weeks.
The European Parliament has on February 16th adopted the Commission proposal for bridging measures for certificates that expire pending MDR conformity assessment. The transitional provisions extends the transition time for certain medical devices under MDR 2017/745 Article 120(3) by risk class as following:
- 31 December 2027 – all class III, and class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors;
- 31 December 2028 – for class IIb other than above, class IIa devices, and class I devices placed on the market sterile, or having a measuring function, or are reusable surgical instrument;
- 26 May 2026 – for class III custom-made implantable devices.
The extension of transition time is combined with an extension of validity of certificates issued under MDD by amending MDR Article 120(2).
Conditions for extension:
- the devices continue to comply with the directives (MDD, AIMDD);
- devices have not undergone significant changes in design or intended purpose;
- the devices do not present an unacceptable risk to health or safety of patients, users, other persons, or other aspects of the protection of public health;
- the manufacturer has put in place a quality management system according to MDR no later than 26 May 2024;
- the manufacturer has lodged a formal application with a notified body no later than 26 May 2024, and have signed a written agreement no later than 26 September 2024.
Also, the sell-off date in Article 120(4) of MDR 2017/745 and the corresponding Article 110(4) of IVDR 2017/746 has been removed, enabling distribution of legacy products until stock is empty.