
11 March 2026Publication
EU proposes overhaul of MDR & IVDR
The EC proposes reforms to simplify MDR/IVDR, ease burdens, boost innovation, and address device shortages, with adoption expected by summer 2026
We’re recognised as a market leader for healthcare & life sciences. Our international team advises the world’s leading and most innovative pharma, biotech, medical device and healthcare companies.
We understand the challenges and the complexities of the sector from regulation to disputes. We provide relevant strategic advice and assistance tailored to each and every situation.
Healthcare & life sciences disputes by their nature are varied. For that reason, we’re more than a team of litigation lawyers - we’re scientists. Many of us have bioscience and pharma law qualifications, we’re analysts, we’re consultants with an in-dept knowledge and experience of your industry. And we’re law shapers.
We share your concerns, we care for your interest and we adapt to protect them. We’ll always put you first, using innovative and creative approaches to get the job done.
Advising 3M UK in its defence of a multi-million dollar Commercial Court claim brought by Porton Capital Technology Funds and others (and their subsequent appeal to the Court of Appeal) This was in relation to allegations of breach of contract arising out of the cessation of the commercialisation of a product developed for the clinical detection of MRSA.
Advising the director of a UK-based pharmaceutical company, in his defence in the High Court and on appeal to the Court of Appeal, against claims of fraudulent and negligent misrepresentation and misstatement. This was in relation to an investment made in the company during its attempted commercialisation in the EU of a protein reverse-engineered from HIV and used for multiple therapeutic applications including treatment of ulcerative diseases of the gut.
Acting for the management of a Dutch biomedical company in inquiry proceedings before the specialised Enterprise Division of the Amsterdam Court of Appeal concerning issues of alleged corporate mismanagement in a hostile take-over context.
If you have any questions, contact a member of the Healthcare and Life Sciences Disputes team for assistance:

11 March 2026Publication
The EC proposes reforms to simplify MDR/IVDR, ease burdens, boost innovation, and address device shortages, with adoption expected by summer 2026

10 February 2026 Publication
New EU Guidelines for human medicines variations apply from 15.01.2026, requiring risk-based, proactive change management and stricter documentation by MAHs.
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08 January 2026 Publication
The EC has published a proposal that may result in (IV)MD no longer being subject to AIA HRAIS requirements.

12 December 2025 Publication
EU agrees on major pharma reform, enhancing innovation, access, and protection—biggest update to pharmaceutical rules in over 20 years.

16 September 2024 Publication
China lifts foreign investment restrictions in Human Stem Cell and Gene Therapy Areas (CGT)