AI Act Approval Elevates Questions on Clinical Investigations, MDR Alignment

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With the text of Europe’s historic AI Act finalized, the focus in the EU shifts to implementation and big questions from the medtech industry about conducting clinical investigations and going through shared AI/MDR/IVDR conformity assessments under the impending regime.

Europe is barreling ahead toward adoption of the AI Act, the first legal framework in the world governing development and deployment of artificial intelligence. But the medical device industry still has a lot of questions about what companies will be facing and how the new requirements will line up with the regulatory gauntlet that already exists for medtech in the EU.

The Act, approved by the European Parliament on March 13, establishes rules for AI applications across all industries, with special obligations for “high-risk” AI, including medical devices that employ advanced algorithms to enhance diagnosis, treatment, and healthcare decision-making. The final negotiated version of the legislation includes language signaling some flexibility with how companies seek compliance with the AI Act in parallel to sector-specific requirements like the Medical Device and IVD Regulations (MDR/IVDR), but there are some elements of the impending law that could fit awkwardly with medtech development pathways.  

“The AI Act is extraordinarily ambitious, and that ambition bumps up quite uncomfortably against specific industries,” says Alex Denoon, a partner with the law firm Bristows who helps life sciences firms on regulatory matters. 


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