in vitro diagnostic

European Commission issued a proposal 2024/0021 (COD) for amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain IVDR.  Once approved by the council and parliament this will give more time for many IVD manufacturers to comply …

Proposal for transitional provisions for certain invitro diagnostic medical devices under Regulation (EU) 2017/746 European Commission issued a proposal (2021/0323 (COD)) for the amendment of the transitional provisions under EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR).  Once approved by the council and parliament this will give more time for many IVD manufacturers …