EU AI Act Regulatory Overlap “Likely To Persist”: Expert Presents Solutions For Dual Conformity

Regulatory overlap with the MDR and IVDR is likely to persist in the finalized AI Act text. However thorough preparation by medtech companies and the use of regulatory sandboxes could help address the need for dual conformity, reports lawyer Elizabethann Wright. 

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The European Parliament and Council of the EU reached a provisional agreement on the proposed AI Act at the end of last year. The final text now needs to be formally adopted by the EU’s co-legislators.

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