Clinical investigations in Great Britain
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How manufacturers should undertake a clinical investigation for a medical device to ensure they comply with medical device regulations.
Adapted edition
- Document type
- Reference Guide
- Format
- DOCX
- Pages
- 13
- Language
- English
- Version
- 1.0
- Updated
- 2026-09-16
- Category
- Safety & operations
- Licence
- Open Government Licence v3.0
Description
How manufacturers should undertake a clinical investigation for a medical device to ensure they comply with medical device regulations. Consult the original guidance for current legal and operational details.
Contents
- When a clinical investigation is required
- Notifying the MHRA of your planned investigation
- Complying with clinical investigation requirements
- Special circumstances requiring particular data
- Change in the intended use or performance claims of a device
- Prototype devices
- Clinical investigations also submitted to the FDA or other regulatory authorities
- Health Institution exempted medical devices
- Off-label use
- Research tools
- Humanitarian use of non-UKCA or non-CE marked devices
- Other factors to consider when planning a clinical investigation
- Number of devices and participants
- Duration
- Type of investigation
- End points
Source and licence
Medicines and Healthcare products Regulatory Agency
AttributionMedicines and Healthcare products Regulatory Agency, ‘Clinical investigations in Great Britain’ (updated 23 July 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