National Medical Devices Committee - Summary of Minutes: 2 September 2025

Attendees and apologies

• Gordon James (Chair), Board Chief Executive, NHS Golden Jubilee Hospital
• Lynsay Gracie, Head of Decontamination and chair of the national Reusable Medical Devices Decontamination Expert Group (RMD-DEG), NHS Greater Glasgow and Clyde
• Chief Medical Officer (CMO) Specialty Advisor for Clinical Physics, Scottish Government
• Head of Digital Health and Care, Scottish Government
• Neil Smart, Chair of Scottish Health Technologies Group (SHTG), Health Improvement Scotland (HIS)
• Kirsty Brightwell, Medical Director, NHS Shetland
• Sulisti Holmes, Head of Incident Reporting Investigation Centre (IRIC)
• Claire Fernie, Public Partner, Health Improvement Scotland (HIS)
• Ewan Bell, Chair of Board Medical Device Committee, NHS Dumfries and Galloway
• Sharon Hilton-Christie, Senior Responsible Officer (SRO), Scan for Safety Programme
• Steven Friel, Chair National Incidents and Alerts Safety Officers (Boards and Local Authorities), NHS Golden Jubilee Hospital
• Malcolm Phillips, Healthcare Science Lead, NHS Lothian
• Stephen Roberts, Head of Medical Physics, NHS Dumfries and Galloway
• Regulatory Policy Medicines and Healthcare products Regulatory Agency (MHRA)
• Yellow Card Policy, Medicines and Healthcare products Regulatory Agency (MHRA)
• AI Innovation and Development, Scottish Government
• Medical Devices Policy, Devolved Governments
• Medical Devices and Legislation Unit (MDLU), Scottish Government

Apologies

• Gregor Smith (Co-chair), Chief Medical Officer, Scottish Government
• Eddie Fraser, Chief Executive, Local Authorities via COSLA
• Head of Chief Medical Officer (CMO) Policy Division, Scottish Government
• Kenny Rees, National Procurement, NHS National Services Scotland (NSS)
• Vanessa Sandison, Chair of Board Medical Device Committee, NHS Grampian

Items and actions

MedTech Regulatory Reform Framework: Updated Health Institution Exemption (HIE)

MHRA colleagues went through a presentation with the MDC on the work they are leading on MedTech Reform. As part of that work, NHS Boards are encouraged to complete the MHRA HIE Survey Stakeholder survey - GOV.UK to ensure that the current use/need for HIE is understood. The MHRA gave assurances to the MDC that the MHRA are engaging and listening to NHS in Scotland, England and Wales about their requirements

Yellow Card Reporting patient participation

The MHRA Yellow Card Scheme is the UK national portal for medicines and medical device safety reporting by patients. An Action Plan to improve patient participation and awareness of the Yellow Card Scheme has been approved by the Committee and implementation started. There was agreement to bring this agenda item back in six months’ time to update on the progress.

Global Citizenship: Medical Equipment donations

The guidance from NHS Assure on medical equipment donations (also applicable to other types of donations) was highlighted for dissemination High-Level Guide to Ethical Donations of Medical Equipment | National Services Scotland