Skip to main content

BETA This is a new service - your feedback (opens in a new tab) will help us to improve it.

Get an overview of your obligations with the data checklist for adopters.

This is required guidance

It is legally required and it is an essential activity.

This Guide covers:

  • England

From:

Adopters - Complying with the UK GDPR Steps 1 - 7: an introduction- Step 6: medical device clinical investigation approval

Reviewed: 13 January 2023

Reviewed by: Health and Care IG Panel

A clinical investigation of a technology is defined as research by the HRA and HCRW and needs approval. You will need to follow the steps described in step 5.

Clinical investigation of a non-CE or non-UKCA marked device

If you plan to do a clinical investigation for a non-CE or non-UKCA marked device, you will need approval from a REC.

How to get a medical device clinical investigation approval from a REC

Step A: Notify the MHRA

You must notify the Medicines and Healthcare products Regulatory Agency (MHRA) before you begin a clinical investigation.

Submit an MHRA devices application to the MHRA. When this is confirmed to be valid, you can submit your application for review on the HRA’s Integrated Research Application System (IRAS). IRAS is a single system for applying for the permissions and approvals for health, social and community care research in the UK. The IRAS form explains what information you need to provide specifically for these types of investigations. See help and guidance on IRAS.

Email: mhracustomerservices@mhra.gov.uk with ‘MHRA/HRA Coordinated assessment pathway’ in the subject line.

Step B: Submit a REC application

Once the MHRA confirms your application as valid, you can submit your REC application on IRAS.

If confidential patient and service-user information is being processed without explicit (common law duty of confidentiality) consent then, as part of your application on IRAS, you will also need to apply to CAG (see further guidance on how to do this on IRAS).

CAG will provide independent advice to the HRA on whether your request for access to the confidential information should be approved based on its assessment criteria. Read CAG’s pre-application assessment before formal submission of an application, which will help you decide whether an application to CAG is an appropriate route.

Updates will be provided (including possible requests for additional information) and a possible meeting with the REC who will do the review. You will then be notified of the decisions, usually by the main email address you have provided and/or that of your sponsor representative.

Get an overview of your obligations with the data checklist for adopters.

This is required guidance

It is legally required and it is an essential activity.

This Guide covers:

  • England

From:

Get more support

To discover how the regulatory organisations can assist you and for contact details, visit our 'Get Support' page.

Is this article useful?

How can we improve this piece?

Error:Select how we can improve this piece
Cancel

Thank you for your feedback!

To share additional insights about this page, please use the following link (opens in a new tab) to submit your observations.

Print this guidance (opens a PDF in a new tab)

Regulations are regularly updated. For the latest information, check the website as printed documents may be outdated.