Orientations réglementaires
FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)
Publié 1 juin 2025
Référence
MDCG 2025-6
Source
MDCG
Thème
New technologies
Publié
1 juin 2025
Langues
EN
© European Union — European Commission, DG SANTE. Reuse under CC BY 4.0.
Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026
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Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Publié 1 juin 2025
Guidance on the safe making available of medical device software (MDSW) apps on online platforms
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Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components
Publié 1 oct. 2023