Interesante este evento en el parlamento europeo sobre la AIA con un apartado relativo al solape con la reglamentación de productos sanitarios:
16:45 – 17:15 Fit for the health sector: Re-imagining MDR/IVDR conformity assessment in light of the AI Act
This session will explore the conformity assessment process of notified bodies designated under the Medical Device Regulation and in vitro Diagnostic Medical Devices Regulation and the potential implications of the AI Act.
Speakers: Andreas Purde, Global Director Functional Safety, Software and Digitization Medical Devices, TÜV SÜD, Geofrey De Visscher, Head of Notified Body, SGS
Moderator: Koen Cobbaert (Senior Manager, Quality, Standards & Regulations, Philips)
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