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Gradual roll-out of EUDAMED and further extension of the transition period for certain in vitro diagnostic devices
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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 in vitro diagnostic medical devices
Initiative summary:
This initiative aims to allow for a gradual roll-out of the different modules of the European database on medical devices (EUDAMED). It also aims to extend the transition period for certain in vitro diagnostic medical devices, in a staggered way and subject to conditions, to avoid shortages of those devices on the EU market.