UK MHRA Med Dev Guidance: Clinical Investigations for Medical Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) provides a detailed framework for conducting clinical investigations of medical devices in the UK. The official guidance  "Clinical Investigations for Medical Devices", updated on 5 September 2025, explains notification requirements, validation steps, applicable fees, and special regional considerations.

This article summarises the key sections of the guidance in a structured format.

Clinical Investigation Enquiries

Clinical investigations involving devices that are not UKCA or CE marked for their intended use must be notified to the MHRA at least 60 days before initiation, through the IRAS portal.

The notification requires:

• Application form

• Investigator’s Brochure (IB)

• Clinical Investigation Plan or protocol

• Technical documentation (including risk analysis and test reports)

• Patient information sheet and consent form

• Evidence of insurance or indemnity

If the MHRA raises no objection within the 60-day period, the investigation may proceed as planned.

MHRA Guidance and Validation Checklist

The guidance clarifies when notification is mandatory and when exemptions apply. For instance, CE/UKCA-marked devices used in accordance with their approved purpose generally do not require notification.

The validation checklist covers:

• Completeness of submitted documentation

• Evidence of ethics approval (HRA/HCRW)

• Correct device classification

• Confirmation of conformity status

• Proof of fee payment

Fees

A fee is payable when giving notice to the MHRA as required under the Medical Devices Regulations 2002.

• Payment details and covered application types are available at MHRA fees.

• For SMEs, flexible payment easements may be available, subject to MHRA approval (provide supporting letter at application submission).

• Evidence of payment should be sent to CI-applications@mhra.gov.uk, quoting your MHRA reference.

Assessment and Combined Review

Applications are typically assessed within 60 days of validation and fee payment. In parallel, approval from a Research Ethics Committee through the Health Research Authority (HRA) or Health and Care Research Wales (HCRW) is required. For studies combining a Clinical Trial of an Investigational Medicinal Product (CTIMP) and a medical device, a combined review route is available, as outlined in the guidance.

Amendments

Any changes to an ongoing investigation—such as updates to the protocol, new trial sites, or revised documentation—must be submitted as an amendment. Submissions include:

• Cover letter with MHRA reference

• Summary of changes and justification

• Both tracked and clean document versions

• Manufacturer’s statement confirming risk assessment

Amendments do not currently attract an MHRA fee.

Early Termination or Temporary Halt

In cases of early termination or temporary suspension of an investigation:

• Notification to MHRA must occur within 15 days (or 24 hours if based on safety concerns).

• A justification must be provided.

• A final study report must be submitted within three months.

Northern Ireland

Clinical investigations conducted in Northern Ireland remain aligned with the EU MDR/IVDR framework. Submissions are managed by MHRA but may include additional regional considerations, particularly regarding post-market studies and sponsor representation requirements.

Healthcare Establishments and Special Cases

Healthcare institutions that design and use devices exclusively for internal patients, without commercial intent, may be exempt from notification. However, if such devices are shared externally or intended for commercialisation, MHRA notification becomes mandatory.

HRA and HCRW Approvals

In addition to MHRA notification, all clinical investigations require approval from the HRA and, where relevant, HCRW. Applications are submitted through the IRAS system, enabling a streamlined process for both regulatory and ethical review.

For definitions, specific document templates, and additional details, always refer to the official MHRA notification guidance