February 17, 2023
The European Parliament has voted overwhelmingly in favor of an amendment to extend transition timelines for the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
The vote occurred on February 16 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers.
Next steps before entry into force
The amendment will enter into force on the date of its publication in the Official Journal of the European Union (OJEU), but first the amendment must be adopted by the European Council (expected by the end of February). Following adoption by the European Council, the formal process of publication in the OJEU may begin, and typically takes up to 30 days.
Key compliance timelines under the amendment
As a reminder, the amendment will set the following transition timelines for affected devices:
- Legacy Class III and Class IIb implantable devices: December 2027
- Legacy Class IIa and Class I devices: December 2028
- Class III implantable custom devices: May 2026
Manufacturers whose CE Mark certificates are set to expire before final publication of the amendment in the OJEU may qualify for temporary market access under Article 97 MDR until new compliance deadlines become official.