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Document 52024PC0043
Gradual roll-out of EUDAMED and further extension of the transition period for certain in vitro diagnostic devices
Proposition de RÈGLEMENT DU PARLEMENT EUROPÉEN ET DU CONSEIL modifiant les règlements (UE) 2017/745 et (UE) 2017/746 en ce qui concerne un déploiement progressif d’Eudamed, l’obligation d’information en cas d’interruption d’approvisionnement et les dispositions transitoires applicables à certains dispositifs médicaux de diagnostic in vitro
- 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.
- EuroVoc thesaurus:
- autorisation de vente; sécurité d'approvisionnement; santé publique; échange d'information; diagnostic médical; marquage CE de conformité; marché unique; matériel médical; système d'information
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- Leading service:
- Directorate-General for Health and Food Safety
- Planned adoption period:
- 01/01/2024 - 31/03/2024
- Check the status of this initiative on the Better Regulation Portal
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- Documents:
- COM/2024/43 final (Proposal for a regulation)
- Leading service:
- Directorate-General for Health and Food Safety
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- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 8