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European AI regulation agreed

On 2 February 2024, the Belgian Presidency announced that the representatives of the EU Member States had already agreed on a final compromise text for the AI Regulation. The agreed position was endorsed by the European Parliament on 13 March 2024. The Regulation will be fully applicable two years after its entry into force, with the exception of some specific provisions which will apply earlier.

AI MDR medical devices Porta Medica

The Regulation is relatively short by EU standards, with a total of 85 articles and 9 annexes. It lays down rules for, among other things, the marketing, commissioning and use of AI systems in the EU; bans on certain AI practices; rules for AI systems designed for emotion recognition and biometric categorisation systems; AI systems used to create or manipulate image, sound or video content; and, of course, rules for monitoring and market surveillance. The AI Regulation applies to providers marketing or operating AI systems in the EU, to users of AI systems in the EU, and to European providers and users of AI-generated outputs anywhere in the world. For the time being, pending any review, the AI Regulation will not apply to, for example, the regulation of civil aviation, all types of motor vehicles, marine equipment and railway systems. Systems developed and operated exclusively for military purposes are completely exempted. However, the regulation will apply to medical devices.

Manufacturers of medical devices will certainly be interested to know whether their devices can now "fall" under the AI Regulation in the "high risk" regime, i.e. with mandatory notified body involvement. Yes, they can - if they are functionally described on the Annex III list, or if both of the following conditions are met simultaneously: (1) the AI system is a device or safety component of a device, and (2) it is a device for which a notified body must participate in the conformity assessment under the MDR or IVDR. For such a device, a single technical file containing all the information set out in Annex IV as well as the information required under the MDR and IVDR shall be produced. The new AI Regulation creates an important new agenda that will need to be intensively monitored in the context of conformity assessment of devices.


 Author: Aleš Martinovský


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