RegulatoryGuideline · final

MHRA publishes overview guidance on bringing software as a medical device to market

🇬🇧 MHRA · Fri 06 Nov 2026

The UK regulator's new guidance sets out key regulatory steps for SaMD manufacturers targeting Great Britain and Northern Ireland, from qualification and classification to MHRA registration.

The Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on 6 November 2026 outlining the regulatory steps to consider when bringing software as a medical device (SaMD) to market in Great Britain and/or Northern Ireland.

The document covers determining whether a piece of software qualifies as a medical device and how it is classified. It then addresses the applicable regulatory route and conformity marking, as well as the standards and guidance relevant to manufacturers.

Where clinical data need to be generated, the guidance also sets out clinical investigation requirements. It closes the process with registration with the MHRA, which is required before a compliant device is placed on the market.

The MHRA also signposts to further MHRA, European and international guidance and standards. It stresses that the information is a helpful starting point rather than an exhaustive list of regulatory requirements.

What it means for your team

  • SaMD developers should use the guidance as an entry point for mapping qualification, classification and route-to-market decisions for Great Britain and Northern Ireland.
  • Teams planning clinical investigations should check the guidance on when clinical data need to be generated.
  • MHRA registration is a required step before placing a compliant device on the market.
  • The guidance is not exhaustive, so regulatory teams should consult the linked MHRA, European and international sources for detailed requirements.

Official guideline text: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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