Amendment Proposal of MDR and IVDR: EU Parliament Approves Proposed Measures

13 May 2024

At the beginning of the year, the European Commission submitted a proposal to the European Parliament and the Council to amend Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). The proposal involved the gradual introduction of EUDAMED, the transitional arrangements for in vitro diagnostic medical devices and the obligation to provide information in the event of supply disruptions.

On 25th April 2024, the European Parliament approved the amendment proposal without changes and forwarded it to the European Council for formal adoption. The amended regulation will then enter into force upon publication in the Official Journal of the European Union.