Clinical investigations for medical devices - How to notify the MHRA of your intention to carry out a clinical investigation for medical devices

Sep 12, 2026

This guidance document from the Medicines and Healthcare products Regulatory Agency (MHRA) outlines the process for notifying the MHRA of the intention to conduct a clinical investigation for medical devices. It details the necessary steps, including understanding MHRA guidance, completing a validation checklist, and submitting relevant information. The document covers specific requirements for studies in Great Britain and Northern Ireland, application procedures under the Medical Device Regulation (EU) 2017/745 (MDR), and how to address clinical investigation enquiries. It also provides information on fees, combined reviews of CTIMP and medical devices, amendments, and early termination procedures. Further sections offer guidance on regulatory advice meetings, electrical safety, statistical considerations, and human factors and usability engineering. This comprehensive guide ensures that manufacturers and sponsors are well-informed about their obligations and the procedures involved in clinical investigations for medical devices within the UK regulatory framework, providing essential details for compliance and successful submission.

LanguageEnglish

CategoryGeneral

FormatPDF

Pages16

Reading Time6 min

AccessFree to download

Clinical investigations for medical devices

How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

Contents

Clinical investigation enquiries
MHRA guidance
Validation checklist
How to notify the MHRA of your clinical investigation
Fees
Assessment
Combined review of a CTIMP and medical device
Amendments
Early termination or temporary halt of a clinical investigation
Northern Ireland
Medical devices: clinical investigations and performance studies in Northern Ireland
Special circumstances for healthcare establishments
Health Research Authority (HRA) and Health and Care Research Wales (HCRW) Approval
More information

FAQs

What is the purpose of this guidance document?

This guidance document from the MHRA explains how to notify them of your intention to carry out a clinical investigation for medical devices. It covers the procedures and requirements involved.

Where can I find information on fees related to clinical investigations?

Information on the fees charged by the MHRA for regulatory advice meetings regarding clinical investigations can be found on the GOV.UK website.

What is required before starting a clinical investigation in Great Britain?

Before starting a clinical investigation in Great Britain, you may need to apply for a UKCA, CE or UKNI marking for your medical device and must inform the MHRA at least 60 days before commencing the investigation.

Sep 12, 2026

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