RegulatoryOfficial

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 placing SaMD on the market in Great Britain and Northern Ireland, but describes itself as a starting point only.

The Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on 6 November 2026 on bringing software as a medical device (SaMD) to market in Great Britain and Northern Ireland. It gives an overview of the regulatory steps and related guidance that manufacturers should consider.

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

Further sections deal with clinical investigation requirements where clinical data need to be generated, and with registration with the MHRA before a compliant device is placed on the market. The guidance also points readers to additional MHRA, European and international guidance and standards.

The MHRA stresses that the information is intended as a helpful starting point and is not an exhaustive list of regulatory requirements. The source description does not identify any new requirements.

What it means for your team

  • Regulatory teams can use the guidance as a structured checklist covering qualification, classification, route to market, conformity marking, clinical investigation and MHRA registration.
  • Because it is not exhaustive, companies should still check the full legal requirements and the detailed guidance it signposts to.
  • Manufacturers targeting both Great Britain and Northern Ireland should note that the guidance addresses both, so route and marking choices may need to be mapped for each market.

Official source: MHRA ↗

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

More Regulatory All →