Clinical investigations for medical devices
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How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Adapted edition
- Document type
- Reference Guide
- Format
- DOCX
- Pages
- 12
- Language
- English
- Version
- 1.0
- Updated
- 2026-09-16
- Category
- Safety & operations
- Licence
- Open Government Licence v3.0
Description
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Consult the original guidance for current legal and operational details.
Contents
- Does my study require a clinical investigation application?
- Special circumstances for healthcare establishments
- Contact us
- Clinical investigation enquiries
- Regulatory advice meetings
- Fees
- Payment for a clinical investigation
- Payment easements for small, and medium enterprises
- Medical device clinical investigation fee waiver programme for micro and small sized enterprises
- Fee waiver programme for micro and small sized enterprises intending to conduct clinical investigations with innovative medical devices
- Fee waiver programme details
- Note:
- Waiver eligibility conditions
- Check whether you meet innovative device criteria
- Waiver Application process
- Further information
Source and licence
Medicines and Healthcare products Regulatory Agency
AttributionMedicines and Healthcare products Regulatory Agency, ‘Clinical investigations for medical devices’ (updated 12 August 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