MHRA Roadmap for Reforming Regulation of Software and AI as Medical Devices in the UK

Purpose and Overall Aims

The Software and AI as a Medical Device Change Programme aims to reform UK medical device regulation to make it fit for purpose for software products, including artificial intelligence (AI). It ensures regulatory requirements are clear and patients are protected, while positioning the UK as a global hub for responsible innovation in medical device software. The programme builds on wider medical device reforms from the Government response to the consultation on future regulation.

The three broad objectives are:

• A. Provide assurance that software and AI as medical devices (SaMD/AIaMD) are acceptably safe and function as intended, protecting patients and the public.
• B. Make requirements clear for manufacturers through guidance, streamlined processes, and tools like designated standards.
• C. Reduce market friction by aligning with UK partners (e.g., NICE, NHS England) and internationally via IMDRF for convergence.

Source: Software and AI as a Medical Device Change Programme roadmap - GOV.UK

Programme Structure

The programme comprises eleven work packages across two workstreams:

• Workstream 1: Reforms across the SaMD lifecycle (Work Packages 1-8, with some absorbed into others).
• Workstream 2: Challenges specific to AIaMD beyond classically programmed software (Work Packages 9-11).

It emphasizes patient-centred approaches, health inequalities, international harmonisation, and collaborations (e.g., with NICE, CQC, HRA via Multi Agency Advisory Service).

Source: Software and AI as a Medical Device Change Programme roadmap - GOV.UK

Key Work Packages

WP 1: Qualification

Addresses clarity on what qualifies as SaMD, ensuring proportionate regulation. Deliverables include guidance on SaMD qualification, crafting intended purpose, and clarifying 'manufacturer' status (e.g., for open-source modifications).

WP 2: Classification

Reforms classification rules to align with risk posed by SaMD, following IMDRF framework. Explores an 'airlock process' (regulatory sandbox) for innovative products and provides guidance on rules.

WP 3: Premarket Requirements

Clarifies data needs for safety, effectiveness, and quality. Includes reviewing essential requirements, best practice guidance (e.g., IEC 62304), human-centred design, and data governance.

WP 4: Post Market

Strengthens surveillance for incidents, real-world evidence use, and change management for software updates. Deliverables cover adverse incident reporting, change protocols, and predetermined change control plans.

WP 5: Cyber Secure Medical Devices

Integrates cybersecurity into requirements and post-market processes, aligning with principles from the Connected Medical Device Security Steering Group.

Additional AI-focused packages (WP9-11) cover good machine learning practice, transparency, bias mitigation, and AI-specific assurance.

Source: Software and AI as a Medical Device Change Programme roadmap - GOV.UK

Timelines and Implementation

Deliverables are released in tranches, with initial drafts (e.g., certain WP1, WP4, WP9 items) targeted before end-2022. The roadmap was updated on 14 June 2023. Legislative changes via secondary legislation follow consultation, with ongoing patient/industry engagement per MHRA strategies.

The programme supports innovation through tools like the AI Airlock sandbox and international alignment.

Source: Software and AI as a Medical Device Change Programme roadmap - GOV.UK

Benefits and Forward Look

This roadmap delivers safer regulation responsive to technological advances, enhances patient safety, reduces duplication, and accelerates responsible innovation in digital health. It positions the UK to benefit from AI/software in healthcare while maintaining high protection standards.