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EU Regulatory Roundup, June 2023: Medtech Shifts Focus To AI, Data And Digital

 
• By Eliza Slawther

The European Commission’s proposed AI Act entered high-level negotiations this month, generating a renewed interest among medtech stakeholders in this upcoming legislation and its impact on the sector.

Top Stories EU

On 14 June, the European Parliament adopted a draft mandate on the proposed Artificial Intelligence (AI) Act that will form the basis of its negotiations with the European Council and European Commission, known as trilogue discussions. The end result of these negotiations, which could conclude by spring 2024, will be a finalized version of the much-debated cross-sectoral regulation.

This news in itself was one of the top 10 most read articles among Medtech Insight subscribers in June,...

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• By Amanda Maxwell

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FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By Elizabeth Orr

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Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges Remain

 
• By Elizabeth Orr

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