National Medical Devices Committee - Summary of Minutes: November 2024

Attendees and apologies

• Head of Chief Medical Officer Policy Division (Chair), Scottish Government
• Head of Diagnostics and General Medical Devices, Medicines and Healthcare products Regulatory Agency (MHRA)
• Clare Thompson, MHRA
• Innes Connor, Incident Reporting and Investigation Centre (IRIC), NHS National Services Scotland
• Jenny Keating, MHRA
• Malcolm Phillips, Healthcare Science Representative, NHS Lothian
• Sharon Hilton-Christie, Senior Responsible Officer (SRO), Scan for Safety Programme       
• Marc Turner, Finance Director, Scottish National Blood Transfusion Service (SNBTS)
• 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, Chief Medical Officer Specialty Advisor for Clinical Physics, Scottish Government
• Steven Friel, Chair, national Incident Safety Officers (Boards and Local Authorities), NHS Golden Jubilee
• Amanda Wong, AHP Director, NHS Fife
• Neil Smart, Chair of Scottish Health Technologies Group (SHTG), Health Improvement Scotland
• Kenny Rees, National Procurement, NHS National Services Scotland
• Claire Fernie, Public Partner, Health Improvement Scotland
• Medical Devices and Legislation Unit, Scottish Government
• Medical Devices Policy Officials, Devolved Governments

Apologies

• Professor Sir Gregor Smith, Chief Medical Officer, Scottish Government
• Gordon James, Board Chief Executive, NHS Golden Jubilee
• Kirsty Brightwell, Medical Director, NHS Shetland
• Eddie Fraser, Chief Executive, Local Authorities, COSLA
• Sulisti Holmes, Head of IRIC       
• Head of Digital Health and Care, Scottish Government
• Head of Innovation Adoption, Scottish Government
• John Gebbie, Director of Finance, NHS 24
• Janette Kennan, Nurse Director, NHS Fife
• Medical Devices Policy Officials, Devolved Governments
• Ewan Bell, Chair of Board Medical Devices Committee, NHS Dumfries and Galloway

Items and actions

The first stage of the future Medical Device Regulatory Framework has been delivered by the Medicine and Healthcare products Regulatory Agency (MHRA) with the Post-Market Surveillance Statutory Instrument laid in Parliament in October, this is expected to be in force by mid-2025. As previously discussed by the MDC, it is important that Board current safety system requirements as set out in CEL (Chief executive letter) 43 (2009) are working effectively in all Boards and Local Authorities. A refreshed CEL 43 (2009) will be published in early 2025 to assist Boards and Local Authorities.

CMO letter “Medical Device Regulation (MDR) Preparedness and NHS Board Medical Devices Policies Guidance” was issued on 30 September 2024 to assist Boards with the development of their Medical Device Policy due to be in place by 31 March 2025. Further support is being provided to Boards through the newly established NHS Board Chairs of local Medical Device Committees Group.

The MHRA launched a supplementary public Consultation on routes to market and in vitro diagnostic devices. The deadline for responses is 5th January 2025 and has been sent to all NHS Board Chairs of Medical Device Committees for their response.

Medical device safety incident reporting and alerting will continue to be a focus for the MDC over the next year with a view to developing a shared understanding of the gaps, challenges and opportunities in medical device safety and alerting.