The MDR Extension is quickly making its way through the channels.

Today the EU Council adopted the Commission’s proposal, after Parliaments positive vote last month. The formal confirmation can be found: HERE

What’s Next?

EU Parliament and EU Council are expected to formally adopt the MDR amendment next week. It will then be published in the Official Journal of the EU (OJEU), entering into force on the day of its publication.

Regarding timing, the amendment is expected to be published in the OJEU shortly after its adoption on 15 March 2023.

Commissioner Kyriakides further states:

“The Commission, together with Member States, notified bodies and the medical industry will continue to work on additional measures to address the structural problems and identify medium and long-term solutions. Ensuring the transition to the new Regulations must be our collective priority to safeguard patient safety and foster innovation in Europe.”

Casus will keep you apprised of continuing updates.