Europe – Trois nouvelles guidances du MDCG en Mars 2020

The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.

Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the EU.

  • Guidance on basic UDI-DI and changes to UDI-DI
  • Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
  • Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software…