A short, but positive update to the proposal to extend the MDR transition period.
As you know, earlier this month the EU Commission issued a proposal to push the MDR transition deadline out until:
- 31 December 2027- Class IIb implantable and Class III devices
- 31 December 2028 – Class IIb (all other), Class IIa, Class I sterile/measuring and Class I self-certified devices
The EU Council has officially accepted the proposal, with no changes. That decision can be found: HERE
The next step is the review (and potential negotiation) by European Parliament, which is expected to occur next month. Once agreement is reached, the legislation will be adopted and then published into the Official Journal of the European Union.
For an overview of the proposal, please read: EU Commission Releases Official Proposal to Extend the MDR Transition Period