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AdoptedOrdinary Legislative2024/0021(COD)

Amendment: Medical Device Regulations (EU) 2017/745 & 2017/746 on Eudamed roll-out and supply

Co-decision by Parliament & Council

Amendment: Medical Device Regulations (EU) 2017/745 & 2017/746 on Eudamed roll-out and supply

This procedure concerns the gradual introduction of a European database for medical devices (Eudamed). It also addresses obligations for suppliers if they interrupt the supply of certain devices and updates transitional rules for specific in vitro diagnostic devices. The changes aim to improve the traceability and availability of medical devices. This affects manufacturers, importers, distributors, and ultimately patients and healthcare providers who rely on these essential products.

EC

Proposal

26 Feb

commission
2

Committee

EP

Parliament

25 Apr

parliament
4

Trilogue

5

Council

OJ

Adopted

9 Jul

publication
7

Published

8

Implemented

9

Closed

No voting data yet. Records appear after plenary roll-call votes.

Commission Proposal

26 Feb 2024

1st Reading (EP)

25 Apr 2024

Adopted

9 Jul 2024

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