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
• By
The UK’s “New Approach” to regulation has created a lot of noise, but what’s the end product? asks Taylor Wessing partner Alison Dennis, who says the UK medtech regulator should look afresh at the EU’s ready-made solution.
• By
US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.
• By
Medtech has not yet been spared from the Trump administration’s trade tariffs, which, for UK exporters will be 10% – half the rate applied to EU27 exporters.
• By
Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.
More from Geography
• By
The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.
• By
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
• By
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.