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Adoption of new amendment to the MDR and IVDR

Adoption of new amendment to the MDR and IVDR

On the basis of the Commission proposal in January 2024, on 25 April 2024 the European Parliament adopted a new amendment to Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as regards a gradual roll-out of the European database on medical devices (Eudamed), the obligation to inform in case of interruption or discontinuation of supply, and the transitional provisions for certain in vitro diagnostic medical devices. After the formal adoption by the Council as well, expected in May, the amending Regulation will enter into force on the day of its publication in the Official Journal of the European Union (OJEU).

The text of the amending Regulation and supporting information are available on the Commission’s webpage on extension of the transition periods provided for in the regulations.

date:  22/05/2024