Medical Devices Committee: terms of reference

Purpose of Medical Devices Committee (MDC)

To provide leadership and offer direction to NHS Scotland in its preparation for the  medical devices regulatory regime due to apply from 2025. 

Responsibilities

The committee will:

• seek to add to preparedness, including by commissioning SLWGs through the SG Medical Devices and Legislation Unit (MDLU) with the relevant Subject Matter Expertise (SME) to develop Once for Scotland approaches and/or national guidance, where possible and considered useful 
• oversee the development of mechanisms to provide assurance of compliance with regulatory and supporting national guidance for NHS boards, particularly through local board medical device policies and ensuring the development of a Monitoring and Improvement Framework, that NHS boards can use to measure their compliance against national guidance
• advise the SG Medical Devices Unit about the delivery of CMO letter 2024(1) “MDR Preparedness and Medical Devices Policy Framework and Action Plan 2024-26” which aims to improve patient and safety and outcomes in medical devices
• where existing national structures are in place, the role of the committee will be to direct those to the most appropriate structures. For example, particular service issues which would be for their respective governance routes such as Diagnostics Steering Group, Digital Portfolio Board or National Infrastructure Board 

Background 

The process to develop future UK Medical Device Regulations (MDR) by the UK Regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) is underway with the future medical device regulations due to apply from 2025. 

These will place new and additional regulatory requirements on NHS boards and local authorities, particularly for in-house manufacture of medical devices, electronic capture and storage of  the Unique Device Identifier for high risk implantable devices and the management of Software as a Medical Device.  

This committee will have a key role in considering advice and guidance to boards about actions that should be taken to ensure effective compliance with the future regime, which will help to improve patient safety and outcomes in the use of medical devices. 

Aligned to the future medical devices regulatory regime and focussed on improving patient safety in medical devices, the SG MDLU published a Medical Devices Policy Framework and Action Plan developed through engagement with NHS boards and Local Authority Incident Safety Officers. Public and patient views are being sought through specific workstreams. 

The framework encompasses several existing programmes of work, including the NHS Scotland Scan for Safety Programme, and importantly will draw on patient insight work recently undertaken by the MDLU on improving the information available to patients on their medical devices.  

The Framework’s aim is to improve patient safety and outcomes in medical devices delivered though four key themes:

• assurance of implementation of UK MDR relating primarily to NHS boards and the application of national guidance on “Management of Medical Devices in health and social care” (SHTN 00-04) in Scotland:
  • improving and utilising medical device data at national level and maximising its use to improve patient safety
  • improving the information available to patients about medical devices used in their care
  • improving infrastructure for medical devices at national level with a first key step to establish this national Medical Devices Committee

Within these themes the Framework is focused on improving the foundations needed to support medical devices policy. Prioritised national actions are being delivered through partnership, particularly with the NHS Scotland Scan for Safety Programme being led by NSS, the national Incident Reporting and Investigation Centre (IRIC) also NSS and with support from Health Improvement Scotland (HIS) and NHS Education Scotland (NES). 

Further Information 

• UK Consultation Document setting out the UK Government intentions for medical device regulation - Consultation on the future regulation of medical devices in the United Kingdom
• MHRA Medical Devices Roadmap and Implementation Plans - Implementation of medical devices future regime 
• Chief Medical Officer Letter CMO(2024)1 – Medical Device Regulation (MDR) Preparedness and Medical Devices Policy Framework and Action Plan 2024-2026
• Directors Letter to NHS Boards CMO(2024)3  - Implementation of NHS Scotland Scan for Safety programme 2024 -2026

Chair and Co-chair

Reflecting the need to work in partnership, the group will be co-chaired by the Scottish Government and NHS Scotland. 

Membership

See the group's membership.

Accountability and reporting 

Reporting to the Chief Medical Officer for SG. 

Secretariat decisions and actions 

The Secretariat will be provided by the SG Medical Devices and Legislation Unit (MDLU). Decisions will be made by consensus within the committee. All decisions and actions will recorded in the decision and action log. 

Frequency and location of meetings 

Meetings will be held at three month intervals using Microsoft Teams. Items may be dealt with by email correspondence between meetings. Meetings will be informed by work and outputs from related programmes and the formation of short life groups to take forward specific areas of work.

Papers 

The agenda and papers will be distributed by email at least five working days prior to the meeting. Decisions and actions will be circulated within 10 working days after each meeting. 

Confidentiality 

Information considered by the committee may be of a sensitive or confidential nature. It is vital that members understand their responsibility to treat as confidential, information that may be available to them, obtained by them, or may be derived by them as a member of the group.

Declarations of interest

All members are required to complete a written Declarations of Interest (DoI) disclosure on an annual basis. At each meeting, members are required to declare relevant interests whether or not they have previously been declared in writing. The Chair will be responsible for considering the actions to be taken when relevant interests have been declared.    

Terms of reference review 

The terms of reference will be reviewed annually by the Chair, co-chair and Secretariat. The first review will be undertaken 12 months from the first meeting. 

Workplan for first 12 months (provisional) 

15 March 2024

• agree terms of reference (agree by email in advance of meeting or after meeting)
• MHRA Regulatory Programme and high impact areas
• deep dive topic from Medical Devices Framework - analysis of board medical device policies and draft guidance

29 May 2024    

• update MHRA Regulatory Programme – focus on Post Market Surveillance Statutory Instrument (SI)
• deep dive topic from Medical Devices Framework – UDI and NHS Scotland Scan for Safety implementation
• discuss opportunities or challenges with MDR compliance for NHS boards

28 August 2024

• update on MHRA Regulatory Programme 
• update on delivery of policy framework actions 
• deep dive topic from Medical Devices Framework – management of software as a medical device
• scan for safety programme update 
• progress on board medical device policies

21 November 2024    

• MHRA Regulatory Programme 
• update on delivery of policy framework actions 
• deep dive topic from Medical Devices Framework – safety and alerting

March 2025    

• review of MDC