National Medical Devices Committee - Summary of Minutes: June 2025

Attendees and apologies

• Medical Devices and Legislation Unit (MDLU) (Chair)
• Head of Diagnostics and General Medical Devices, Medicines and Healthcare products Regulatory Agency (MHRA)
• Nicky Waters, Scan for Safety Programme Director
• Kirsty Brightwell, Medical Director, NHS Shetland
• Amanda Wong, Allied Health Professionals (AHP) Director (NHS Fife)
• Lynsay Gracie, Head of Decontamination and chair of the national Reusable Medical Devices Decontamination Expert Group (RMD-DEG), NHS Greater Glasgow and Clyde
• Andrew Reilly, Specialty Advisor for Clinical Physics, Scottish Government
• Sulisti Holmes, Head of Incident Reporting Investigation Centre (IRIC)
• Neil Smart , Chair of Scottish Health Technologies Group (SHTG), Health Improvement Scotland (HIS)
• Kenny Rees, National Procurement, NHS National Services Scotland (NSS)
• AI Innovation and Development, Scottish Government
• Iain Robertson         SG Medical Devices and Legislation Unit (MDLU)
• Medical Device Policy Officials, Devolved Governments
• Sharon Hilton-Christie, Senior Responsible Officer (SRO), Scan for Safety Programme
• Stephen Roberts, Head of Medical Physics, NHS Dumfries and Galloway

Apologies

• Gordon James, Board Chief Executive (Co-Chair), NHS Golden Jubilee Hospital
• Head of Chief Medical Officer (CMO) Policy Division, Scottish Government
• Gregor Smith, Chief Medical Officer (Co-Chair), Scottish Government
• Janette Kennan, Nurse Director, NHS Fife
• Marc Turner, Director, Director Scottish National Blood Transfusion Service (SNBTS)
• Eddie Fraser, Chief Executive, Local Authorities via COSLA
• Steven Friel, Chair of national Incident Safety Officers (Boards and Local Authorities), NHS Golden Jubilee Hospital
• Claire Fernie, Public Partner, Health Improvement Scotland (HIS)
• Ewan Bell, Chair of Board Medical Device Committee, NHS Dumfries and Galloway
• John Gebbie, Director of Finance, NHS 24
• Malcolm Phillips, Healthcare Science Lead, NHS Lothian
• Chief Scientist Office, Scottish Government

Items and actions

Board Medical Device Policies

As part of Board preparedness for the future Medical Device Regulations, most NHS Boards now have a Board Medical Device Policy (including those in draft) that include their system of governance and links to the Board safety structures. This is a significant increase from the baseline in 2024. As part of increasing the transparency on medical devices final policies should be published on Board websites.

New MHRA Health Institute Exemption (HIE) guidance is due to be published by the MHRA in July 2026.

This is being informed by discussion with NHS Boards who have provided visits to their on site manufacturing sites. The SG Medical Devices and Legislation Unit expect that the Guidance will include the requirements that were outlined in the United Kingdom Government (UKG) consultation response published in June 2022 and include: requirement for In House Manufactured Devices to be registered on the MHRA Medical Device Register, require a Quality Management System, retention of technical documentation, to register clinical investigations and performance studies and provisions for adverse event reporting.

Yellow Card Reporting for patients

An Action Plan to increase patient awareness of reporting medical device safety issues to the MHRA Yellow Card scheme is being developed and will be discussed at the next MDC meeting.