Regulatory
Overview
The Medical Device and IVD Regulatory Groups are ABHI's primary forums for regulatory policy, intelligence-sharing and stakeholder engagement. The groups support members across medical devices, in vitro diagnostics, software and AI-enabled technologies, shaping ABHI's positions on UK, EU and international regulatory developments and helping ensure timely patient access to safe and effective HealthTech products.
The groups work collaboratively with other ABHI member groups to ensure new UK and EU regulations support patient safety, innovation and timely access to medical devices, IVDs and digital health products.
The MD and IVD Regulatory Groups work closely with ABHI's Digital Health team to address regulatory issues affecting software, AI-enabled technologies, digital therapeutics and connected health technologies. Work includes UK regulatory reform, AI governance, international convergence and NHS adoption requirements.
Leadership
Medical Device Regulatory
- Chair Cait Gatt - BD
- Vice Chair Clare Huntington - Pennine, Darren Thain - Smith+Nephew, Roland Back - Abbott
IVD Regulatory
- Chairs Sue Spencer - Compliance Connextions & Megha Iyer - ThermoFisher Scientific
- Vice Chair Caroline Alexander - Genedrive
Achievements
- Provided significant industry input to the development of the UK's future regulatory framework for medical devices, IVDs and software, including detailed engagement on pre-market reform, recognition and reliance, classification, common specifications and wider MHRA consultations.
- Established the regulatory groups as a key forum for regulatory intelligence, bringing together senior representatives from industry, MHRA, MedTech Europe, international trade associations and other stakeholders to discuss emerging regulatory developments and implementation challenges.
- Influenced policy discussions on recognition of CE marked products in Great Britain, transition arrangements, international reliance pathways and measures to support timely patient access to innovative HealthTech.
- Coordinated member engagement on major regulatory issues including MHRA fees, service performance, EUDAMED implementation, IVDR transition, post-market surveillance and the future operation of UK and EU regulatory systems.
- Strengthened collaboration with international partners, including MedTech Europe and national trade associations, to support greater alignment and convergence across UK, European and global regulatory frameworks.
- Supported the development of ABHI positions on software, AI-enabled medical devices and digital health regulation, ensuring these technologies are considered alongside medical devices and IVDs within evolving regulatory frameworks.
- Participated in the AI Commission, providing extensive industry commentary to inform its work and ensure HealthTech perspectives on AI-enabled medical devices and digital health regulation were reflected.
- Contributed industry perspectives to the development of the MHRA Strategy 2030 and other strategic initiatives, promoting a regulatory environment that supports patient safety, innovation and the competitiveness of the UK HealthTech sector.
Priorities
- Support members to implement regulatory requirements and navigate change.
- Shape UK regulatory reform to improve patient access, innovation, growth and access to the UK market.
- Monitor and influence EU & international regulatory developments affecting member access to UK and global markets.
Useful Resources
Click here to view the latest updates, resources, minutes and future meeting dates for the group.
Get Involved
To join the ABHI Medical Device Regulatory group, ABHI IVD Regulatory group or ABHI Digital Regulation subgroup, contact stephen.lee@abhi.org.uk or bayode.adisa@abhi.org.uk
