The new EU AI regulation proposal, medical devices and IVDs

Now this is fun: at a time just before the date of application of the MDR when we do not even have harmonised standards for the new software requirements in Annex I, section 17 MDR and Annex I, section 16 IVDR, the Commission proposes new mandatory regulation to supplement the the MDR and the IVDR that overlaps mostly with the MDR and IVDR. Ladies and gentlemen, I give you the proposal for a a regulation laying down harmonised rules on artificial intelligence (the Artificial Intelligence Act for sh [...] « Read the rest of this article on medicaldeviceslegal »