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Update MDCG 2019-11 rev.1 – Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (June 2025)

This document, which primarily targets Medical Device Software (MDSW) manufacturers, provides guidance on:

  • the criteria for the qualification of software falling within the scope of the Medical Device Regulations, including Medical Device Artificial Intelligence,
  • the application of the classification criteria under those regulations to MDSW, and
  • information related to placing on the market MDSW.

Read the news announcement published by Directorate-General for Health and Food Safety on 17 June 2025.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (21 juillet 2025). Update MDCG 2019-11 rev.1 – Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (June 2025). ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/14e9o


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