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Regulating medical devices in the UK

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ByMedicines and Healthcare products Regulatory Agencysage_otter_7e55f6

What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.

Adapted edition

Medical device safety
Document type
Reference Guide
Format
DOCX
Pages
11
Language
English
Version
1.0
Updated
2026-09-16
Category
Safety & operations
Licence
Open Government Licence v3.0
Description

What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. Consult the original guidance for current legal and operational details.

Contents
  • Overview
  • Summary of key requirements for placing a device on the Great Britain market
  • Legislation that applies in Great Britain
  • The EU Medical Devices Regulation and EU in vitro Diagnostic Medical Devices Regulation
  • The role of the MHRA
  • Requirements for those manufacturing and supplying devices in Great Britain
  • Registrations in Great Britain
  • UK responsible person
  • Importers and distributors
  • UKCA mark and conformity assessment bodies
  • UKCA marking
  • UK approved bodies
  • Class I medical device and general IVD manufacturers
  • CE marking and notified bodies
  • CE marking
  • EU notified bodies
Source and licence
Regulating medical devices in the UK

Medicines and Healthcare products Regulatory Agency

Original source OGL-UK-3.0

AttributionMedicines and Healthcare products Regulatory Agency, ‘Regulating medical devices in the UK’ (updated 20 February 2026), reused under the Open Government Licence v3.0.

ChangesNeutral text-only adaptation from the official GOV.UK Content API body: headings, paragraphs, ordered and unordered list items and clickable source-link destinations in an appendix preserved. Images, logos, page design, accessible-format request widgets and linked attachments excluded; normalised whitespace, invisible format marks and typography.

Version history
  • v1.016/09/2026
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