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.
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.

More from Europe
The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.
Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.
As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.
Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.
More from Geography
Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.
People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.
Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.