SaMD (Software as a Medical Device) Key Regulatory Developments (2025)

The regulatory landscape for Software as a Medical Device (SaMD) in the UK is undergoing significant transformation. With key changes from the MHRA and new legislation, manufacturers must stay ahead of the curve to ensure compliance and market access. Here’s a breakdown of the critical updates you need to be aware of.

1. Updated MHRA Guidance – Software & AI as a Medical Device

• On 3 February 2025, the MHRA refreshed its guidance on Software and Artificial Intelligence as a Medical Device (SaMD and AIaMD). The update adds:
  • A link to guidance specifically on Digital Mental Health Technology (DMHT)—helping manufacturers assess qualification and classification under medical device regulations.
  • Supporting clarity on transparency for machine-learning devices and the use of Predetermined Change Control Plans (PCCPs).
    (GOV.UK, Regulatory Affairs)

2. Mandatory Vigilance Reporting Guidance

• On 15 January 2025, MHRA issued new guidance for manufacturers on reporting adverse incidents involving SaMD. It clarifies that many serious incidents related to software stem from indirect harm—such as incorrect clinical decisions based on SaMD outputs—and must be reported under existing regulatory criteria.
  (GOV.UK)

3. Medical Devices (Amendment) (Great Britain) Regulations 2025

• Came into force on 24 May 2025. These amendments amend the UK Medical Devices Regulations 2002 to ensure continuity of regulation post-Brexit by retaining key EU-derived provisions.
• They delete four EU-originated regulations (e.g., related to eIFU, approved body oversight) that were scheduled for revocation, preventing a regulatory vacuum.
  (Legislation.gov.uk, sushvin.com)

4. Pre-Market Regulatory Reform & International Alignment

• The UK is moving toward stronger pre-market requirements and international alignment, especially for SaMD:
  • New reforms propose that SaMD will largely shift from self-certification (Class I) to Class IIa, aligning UK regulation with other jurisdictions (e.g., EU, US).
  • A proposed “Route 4” approval pathway would allow devices approved by comparable regulators (e.g., FDA, TGA, Health Canada) to be accepted in the UK via a streamlined process, with additional scrutiny on risk, classification, and post-market surveillance.
    (Penningtons Law)

5. Broader Regulation Framework – Including Cybersecurity

• As part of broader pre-market reform, UK government guidance adds:
  • Cybersecurity requirements for SaMD and AI-based medical devices.
  • Measures such as Unique Device Identification (UDI), improved technical documentation, and alignment with EU essential requirements to support patient safety and international harmonisation.
    (GOV.UK)

6. Ongoing Reform Pathways into 2026

• A broader reform roadmap indicates:
  • Post-market surveillance amendments took effect from June 2025.
  • Pre-market regulation changes, including up-classification of SaMD, UDI mandates, and international recognition frameworks, are expected to be implemented in 2026.
    (Mantra Systems, periculo.co.uk)

Summary Table

Real-World Illustration

Imagine a UK startup developing an AI-powered mental health app:

• Now: They must refer to the latest MHRA guidance (Feb 2025) to determine if their app counts as a SaMD under UK rules, especially in mental health.
• If it is a SaMD: They must ensure vigilance systems are in place—reporting any clinical mis-diagnosis or harm via the Yellow Card system.
• From 2026: If similar software is already approved in a “comparable jurisdiction,” the company could leverage the Route 4 pathway for faster UK market access, but expect more documentation, including cybersecurity, UDI, and robust classification.

Straightforward Key Takeaways for Developers/Manufacturers

• Use the latest guidance: Updated on 3 Feb 2025—especially for digital mental health tech.
• Reporting now matters: Any serious incident (even indirect harm) must be reported under vigilance rules refreshed Jan 2025.
• Regulatory certainty: The May 2025 amendment ensures no regulatory gaps following EU transition.
• Prepare for 2026 changes: Expect stronger pre-market scrutiny, higher classification of SaMD, and international acceptance routes.