National Medical Devices Committee - Summary of Minutes: December 2025

Attendees and apologies

• Head of Chief Medical Officer (CMO) Policy Division, Scottish Government
• Gordon James (Chair), Board Chief Executive, NHS Golden Jubilee Hospital
• Eddie Fraser, Chief Executive, Local Authorities via COSLA
• Lynsay Gracie, Head of Decontamination and chair of the national Reusable Medical Devices Decontamination Expert Group (RMD-DEG), NHS Greater Glasgow and Clyde
• Steven Friel, Chair, national Incident Safety Officers (Boards and Local Authorities), NHS Golden Jubilee Hospital
• Claire Fernie, Public Partner, Health Improvement Scotland (HIS)
• Kenny Rees, National Procurement, NHS National Services Scotland (NSS)
• Ewan Bell, Chair of Board Medical Device Committee, NHS Dumfries and Galloway
• John Gebbie, Director of Finance, NHS 24
• Paul Westwood, Consultant Clinical Scientist, NHS Greater Glasgow and Clyde
• Chief Medical Officer (CMO) Specialty Advisor for Clinical Physics, Scottish Government
• Scottish Health Technologies Group (SHTG), Health Improvement Scotland (HIS)
• Neil Smart, Scottish Health Technologies Group (SHTG), Health Improvement Scotland (HIS)
• Chief Scientist Office Policy Official, Scottish Government
• Medical Devices and Legislation Unit (MDLU), Scottish Government
• Medical Devices Policy Officials, Devolved Governments

Apologies

• Gregor Smith, Chief Medical Officer (Co-Chair), Scottish Government
• Janette Keenan, Nurse Director, NHS Fife
• Head of Digital Health and Care, Scottish Government
• Marc Turner, Director, Scottish National Blood Transfusion Service (SNBTS)
• Vanessa Sandison, Chair of NHS Board Medical Devices Committee, NHS Grampian
• Head of Diagnostics and General Medical Devices, Medicines and Healthcare products Regulatory Agency (MHRA)
• Kirsty Brightwell, Medical Director, NHS Shetland
• Malcolm Phillips, Healthcare Science Lead, NHS Lothian
• Sulisti Holmes, Head of Incident Reporting Investigation Centre (IRIC)
• Amanda Wong, Director of Allied Health Professionals (AHP), NHS Fife
• Sharon Hilton-Christie, Senio Responsible Officer (SRO), Scan for Safety Programme

Items and actions

Medical Device Regulation Preparedness

Pace is now picking up with the draft GB Medical Devices Regulations due to be published in January 2026. Following this, Scottish Government Medical Devices and Legislation Unit (SG MDLU) plan to issue targeted communications to highlight key actions NHS Boards are required to take specifically in relation to the NHS Scotland Scan for Safety implementation and healthcare provider requirements for implant cards. In January 2026, the NHS National Services Scotland, Incident Reporting and Investigation Centre (IRIC) will issue a Safety Systems Compliance Survey for Boards and Local Authorities for them to assess their safety systems are compliant with national requirements. All NHS Boards were required to publish their Board Medical Device Policy by March 2025 – any Board who has not done this is required to ensure that their policy is published as soon as possible.

MHRA Guidance on Health Institution Exemption (HIE)

Guidance is due to be issued by the MHRA shortly on NHS Board use of health institution exemption. HIE for general medical devices is not being included in the GB Medical Device Regulations at this stage. The new MHRA Guidance will require NHS Boards to have systems in place to ensure appropriate governance, asset management, quality management and adverse event reporting are in place. Further advice from SG MDLU will follow.

Strengthening Scotland’s Health Technology Pipeline

NHS Boards are reminded that they can directly commission the Scottish  Health Technologies Group (SHTG) in Healthcare Improvement Scotland  to undertake Health Technology Assessments on technologies to be used by Boards and the value that these bring to local and national device developments. For assessments that relate to medical devices, the MDC agreed that Board Medical Device Committees could provide a good landing place for SHTG assessments and would be well positioned to co-ordinate a Board response.