DISPOSITIFS MEDICAUX (DM) : publication de guides MDCG

DISPOSITIFS MEDICAUX :
-    Octobre 2024 >> MDCG 2022-5 rev.1 - Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

-    Novembre 2024 >> MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED

EUDAMED : Novembre 2024 >> Gradual roll out of EUDAMED - Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices1

DISPOSITIFS MEDICAUX DE DIAGNOSTIC IN VITRO >> MDCG 2024-11 - Guidance on qualification of in vitro diagnostic medical devices (Oct. 2024)

Article 10a – interruption or discontinuation of supply – Déc. 2024:
-    Q&A rev.1 - Q&A Obligation to inform in case of interruption or discontinuation of supply
-    MDCG 2024-16 - Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices
-    MDCG 2024-16 Annex - Device Identification table

STANDARDS >> MDCG 2021-5 rev.1 - Guidance on standardisation for medical devices (Juillet 2024)

UDI >> MDCG 2024-14 -     Guidance on the implementation of the Master UDI-DI solution for contact lenses (Nov. 2024)

>> Ces guides sont consultables ICI.

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