Summary:
L’Union européenne a publié des lignes directrices pour aider les fabricants de dispositifs à naviguer dans le chevauchement réglementaire entre les réglementations sur les dispositifs médicaux et l’Acte sur l’intelligence artificielle. Ce document vise à clarifier les exigences en matière de tests cliniques et de décisions concernant les modifications significatives des dispositifs d’intelligence artificielle médicale, en facilitant la conformité réglementaire tout en maintenant la sécurité et l’innovation.
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Original Article:
EU Publishes Guidance On Interplay Between AI Act And Medtech Regulations
Commission Sets Out Rules On MDAI – Medical Device Artificial Intelligence
25 Jun 2025
By Amanda Maxwell
The European Union has issued new guidance designed to help device manufacturers navigate the regulatory overlap between the EU’s Medical Device and In Vitro Diagnostic (IVD) Regulations and the Artificial Intelligence Act (AIA). The document, jointly produced by the European Commission’s Joint Artificial Intelligence Board and the Medical Device Coordination Group, addresses various challenges arising in this domain.
One major topic covered in the guidance is the overlapping requirements for clinical testing and decision-making concerning significant changes to Medical Device Artificial Intelligence (MDAI). Compliance with multiple regulations for the same product has proven to be a uniquely challenging endeavor for manufacturers. The guidance aims to clarify processes and help streamline pathways for regulatory compliance without compromising safety and innovation.
Device manufacturers must address both the classification and risk management challenges posed by products falling under the scope of both sets of regulations. As AI continues to play a pivotal role in medical technology, the guidance is expected to provide much-needed clarity for stakeholders navigating this complex regulatory landscape.