National Medical Devices Committee - Summary of Minutes: April 2026

Attendees and apologies

• Chief Medical Officer (CMO) Specialty Advisor for Clinical Physics (Chair), Scottish Government
• 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, Public Services Delivery Scotland (PSDS)
• 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
• Sulisti Holmes, Head of Incident Reporting Investigation Centre (IRIC)
• Stephen Roberts, Head of Medical Physics, NHS Dumfries and Galloway
• Policy Official, Chief Scientist Office, Scottish Government
• Head of Diagnostics and General Medical Devices, Medicines and Healthcare products Regulatory Agency (MHRA)
• Policy Official Chief Scientist Office, Scottish Government
• Emily Hargreaves (deputising for Marc Turner) Director Scottish National Blood Transfusion Service (SNBTS)
• Janette Keenan, Nurse Director, NHS Fife
• Medical Devices Policy Officials, Devolved Governments
• Medical Devices and Legislation Unit (MDLU), Scottish Government
• Simon White, Director, Scan for Safety Programme

Apologies

• Head of Chief Medical Officer (CMO) Policy Division, Scottish Government
• Gregor Smith, Chief Medical Officer (Co-Chair), Scottish Government
• Head of Digital Health and Care, Scottish Government
• Kirsty Brightwell, Medical Director, NHS Shetland
• Lynsay Gracie, Head of Decontamination and chair of the national Reusable Medical Devices Decontamination Expert Group (RMD-DEG), NHS Greater Glasgow and Clyde
• Amanda Wong, Allied Health Professionals (AHP) Director, NHS Fife
• Eddie Fraser, Chief Executive, Local Authorities via COSLA
• Vanessa Sandison , Chair of NHS Board Medical Devices Committee, NHS Grampian
• Malcolm Phillips, Healthcare Science Lead, NHS Lothian
• Neil Smart, Chair of Scottish Health Technologies Group (SHTG), Health Improvement Scotland (HIS)
• Sharon Hilton-Christie, Senior Responsible Officer, Scan for Safety Programme

Items and actions

Scan for Safety Programme

The NHS Scotland Scan for Safety Programme is being implemented in all NHS Boards to provide traceability of implantable devices linked to the patient providing a system wide approach to improve patient safety and meet GB regulatory requirements for healthcare providers in the planned GB Medical Device Regulations. MDR Preparedness: NHS Scotland Scan for Safety Directors Letter (2026)01 was issued on 28 January 2026 to: remind Boards of the time limited assistance available until March 2027, outline arrangements for the Business as Usual/Target Operating Model from March 2027 and to offer to NHS Boards support from the PSD (Public Service Delivery) Scotland Programme Implementation Team in undertaking an evaluation of their planned Board activity to progress implementation, within all specialties using implantable devices to provide assurance of regulatory compliance to the Board local governance structure. Chief Executives are asked to support the action required to ensure that their Board has appropriate plans in place to achieve their regulatory requirement for implantable devices.

Quality Management Systems for medical devices

With an increased focus on Quality Management Systems, it is anticipated that the GB Medical Device Regulations will have implications for NHS Boards who manufacture medical devices by expanding requirements for externally certified QMS (Quality Management system) to both manufactured and custom made devices. Boards that are utilising Health Institute Exemption to manufacture devices are directed to the recently published guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) Health Institution Exemption for general medical devices - GOV.UK

Patient Participation

Patient Participation is an important part of Post Market Safety Surveillance for medical devices. Awareness by health and care professionals and members of the public is limited, that in addition to reporting to their health or care professional, patients and members of the public can report medical device safety concerns directly to the MHRA Yellow Card Scheme. The Committee were updated on actions to improve awareness including a range of public information now available on NHS Inform, Care Information Scotland and mygov.scot to sign post to the MHRA. Through closer working with Medicines Policy, the MHRA Medicines and Medical Devices Safety Toolkit has been shared with all GP practices and community pharmacies in Scotland. Work is also progressing with the MHRA to reduce the barriers to patient reporting with a review of the Patient Reporting form being undertaken. Further work will also be progressed in collaboration with the national Incidents and Alerts Safety Officers Network.