Medical devices: conformity assessment and the UKCA mark
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How to conform with the legal requirements for placing medical devices on the market.
Adapted edition
- Document type
- Reference Guide
- Format
- DOCX
- Pages
- 4
- Language
- English
- Version
- 1.0
- Updated
- 2026-09-16
- Category
- Safety & operations
- Licence
- Open Government Licence v3.0
Description
How to conform with the legal requirements for placing medical devices on the market. Consult the original guidance for current legal and operational details.
Contents
- Overview
- Assessment routes
- Class I devices
- Class IIa devices
- Class IIb devices
- Class III devices
- In vitro diagnostic medical devices
- More information
- Compliance with designated standards
- Clinical investigations
- The UKCA mark
- Exemptions
- Northern Ireland
Source and licence
Medicines and Healthcare products Regulatory Agency
AttributionMedicines and Healthcare products Regulatory Agency, ‘Medical devices: conformity assessment and the UKCA mark’ (updated 13 May 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