Proposed Amendment to MDR Transition Period

During today’s EPSCO meeting, a proposed amendment to Regulation (EU) 2017/745 was made in order to introduce an extended and staggered transition to the MDR’s requirements. This follows various MedTech groups voicing their concerns on the subject and presumably research conducted by the relevant working groups.

The proposed blockbuster amendment is expected early 2023 and includes:

1) New staggered extension to Article 120(3) transitions:

  • High Risk Devices: 2027 (Class III &…IIb?)
  • Medium-Low Risk: 2028 (Class IIa, up-classified class I)

2) Removal of 2025 sell-off date.

3) New regulatory pathways and support for orphan and breakthrough products. Including a new pilot program to help provide assistance to SMEs.

We should know more in the coming days.