Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

Medical device definition

What does Medical device mean? In legal practice, a medical device is a product intended by its manufacturer to diagnose, prevent, monitor, predict, treat or alleviate disease or injury in humans, or to investigate, replace or modify anatomy or a physiological process, whose principal intended action is not achieved by pharmacological, immunological or metabolic means (though such means may assist). It includes instruments, apparatus, appliances, implants, materials and standalone software, used alone or in combination. Reagents and related articles used with devices are covered; in vitro diagnostic items are regulated in parallel. The term is defined in legislation. In Great Britain, see the Medical Devices Regulations...

Medicines and Medical Devices Act 2021: UK post-Brexit regulatory powers for human medicines, clinical trials and medical devices; enforcement, information sharing, Patient Safety Commissioner, and commencement timeline

Published by a LexisNexis Life Sciences expert

Practice notes

This Practice Note summarises the (MMDA 2021). In short, it establishes a Commissioner for Patient Safety for matters concerning human medicines and medical devices, enables post-implementation updates to UK regulatory frameworks for medicines and devices, consolidates device enforcement, and permits information-sharing on devices.

It sets out the legal context and objectives of MMDA 2021, charts its legislative progress, and reviews the principal provisions on human medicines, clinical trials and medical devices:

Background and purposes of the
Overview of the
Part 2—Human medicines
Part 4—Medical devices
Timeline of legislative procedure and commencement

This Practice Note does not detail the stages of secondary legislation made under MMDA 2021. For further analysis, see News Analysis: Analysing the . For notable secondary legislative developments under MMDA 2021, see Practice Note: Life sciences tracker—UK.

Background and purposes of the

A significant portion of the UK legal regime for medicinal products and medical devices stems from EU law (regulations and directives), which has been given effect and implemented domestically in the UK through the...

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Web page updated on 21/05/2026

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