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08 January 2026Publication
EC plans AI in vitro medical device rule changes
The EC has published a proposal that may result in (IV)MD no longer being subject to AIA HRAIS requirements.
Healthcare and life science businesses trust us for our in-depth knowledge of this highly-regulated sector. And because our integrated teams deliver exceptional technical expertise and service.
Our global team is dedicated to the full legal scope of healthcare and life sciences, including intellectual property, product liability, competition/antitrust, tax, corporate, employment, investment and finance.
We provide a single source of expert advice across the sector, collaborating closely between practices and across our international network.
That’s why our clients include 18 of the world’s top 20 pharmaceutical companies, global medical device manufacturers, household-name consumer brands, healthcare services businesses and innovative startups
We’re especially active in the world of digital health, combining our experience in both healthcare and technology.
We take pride in delivering exceptional service to our clients. Secondments give our team invaluable experience and insight, and help us to help you plan for future growth. We’re also actively involved with trade associations like EFPIA, and the national associations wherever we work across the world.
The result: comprehensive, consistently high-quality advice. Not just on the details of healthcare legislation, but on commercial strategies for driving your business forward.
What lies ahead for the future of the healthcare and life sciences sector? Hear from Sector Head Alexandre Regniault in this short video.
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