The EU Commission proposed targeted amendments to the Medical Device Regulation (MDR 2017/745) on 6.1.2023. The proposal follows the persistent calls of the EU health ministers and the industry highlighting the challenges in the implementation of the MDR. These challenges have arisen primarily from the limited resources of notified bodies required to certify devices for conformity under the new legal framework.
In short, the proposal includes the following amendments:
- Extension of transitional period in Article 120(3) for legacy devices:
- until the end of 2027 for Class IIb and III devices
- until the end of 2028 for Class I devices (the ones requiring NB assessment) and IIa devices
- Provision of a conditional extension of validity period for CE certificates issued under the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), on the following conditions:
- the devices must continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable
- the device does not present an unacceptable risk to health and safety
- the device has not undergone significant changes in design or intended purpose
- no later than 26 May 2024, the manufacturer has put in place a quality management system (QMS)
- no later than 26 May 2024, the manufacturer, or its authorised representative, has lodged a formal application for conformity assessment, and no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement. This condition aims to ensure that only devices that the manufacturer intends to transition to the MDR will benefit from the extended transition period.
- Removing the “sell-off” provision in Article 120(4) that currently permits devices certified under the MDD and AIMDD regime to be placed on the market only until 26 May 2025.
Regardless of the prolonged transitional period, the time to act is now. The Medfiles MD team is happy to help you and your company to prepare for the MDR amendments!