How ABHI Will Support You Through Regulatory Change In 2026
Topic : Regulation Type : Briefing
A message from ABHI's Regulatory Directors, Steve Lee & Phil Brown
2026 will be a significant year for HealthTech regulation. As major reforms come into force across UK and EU frameworks, supporting members will be a central priority for ABHI, with a clear emphasis on practical delivery, clarity, and engagement.
The UK regulatory context is changing and evolving to support innovation, while protecting patients. The MHRA has already updated legislation on post-market surveillance and is now set to introduce the next phase of changes to UK regulation. At the same time, regulatory reform is underway in the EU, alongside broader international efforts to improve regulatory alignment and convergence.
Building on our existing regulatory communications, we are developing an ambitious programme of member activity for the first quarter of 2026, bringing together anticipated MHRA legislation, UKCA and CE marking developments, reliance routes, and the evolving EU MDR and IVDR landscape. This work is informed by ABHI’s active engagement in international regulatory forums, including the International Medical Device Regulators Forum, helping to ensure members’ perspectives contribute to global regulatory convergence. This programme will include a series of member briefings, interactive webinars, in-person workshops, and policy and briefing papers, shaped by structured input from our members.
This work reflects a clear commitment from ABHI’s Board, Chair, and Chief Executive to ensure the sector is well supported through what will be a complex and fast-moving regulatory environment. Our priority is to help members understand what is changing, what it means in practice, and how best to prepare, while continuing to represent your interests with UK and international regulators.
With this scale of activity planned, 2026 presents a real opportunity to ensure your teams are fully engaged with ABHI’s work. Your insight and experience will be critical to informing our positions, shaping our advocacy, and ensuring that reforms work for patients, the NHS, and the HealthTech sector. We will share regular updates, and as always, we are keen to hear from members with your thoughts and views on how ABHI can best support you, so please do get in touch.
Not yet a member of ABHI? Get in touch to find out how we can support you in 2026 and beyond.
Join our 23rd January Member Briefing to hear about our work and priorities for 2026.