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MHRA / HRA Coordinated pathway

Published 9 June 2023

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This publication is available at https://www.gov.uk/government/publications/mhra-hra-coordinated-pathway/mhra-hra-coordinated-pathway

Overview

The MHRA in partnership with the HRA can offer a new coordinated assessment pathway which will streamline the review of clinical investigations involving medical devices. This assessment pathway will benefit applicants by ensuring the MHRA review, and the Research Ethics Committee (REC) review are undertaken in parallel, and information will be shared.

MHRA is collaborating with the HRA on the coordinated assessment pathway which involves our two organisations sharing information during our assessment of medical device clinical investigations. For this process we require the MHRA Devices application to be submitted first and then the REC application to be submitted as soon as MHRA has confirmed the devices application to be valid.

Please note, your application cover letter MUST also state that you wish to participate in the coordinated assessment

Our two organisations will then share information on our findings with each another. It is envisaged that the MHRA assessment will be shared with the REC before the REC meeting and the REC discussion will be shared with MHRA.

How to participate

You must be in a position where both the MHRA Devices and REC applications have been prepared and are ready to be submitted.

The application to MHRA Devices will need to be submitted first and the application to REC can only be submitted once MHRA has confirmed that the devices application is valid, therefore both applications should be ready to be submitted at the time of submitting the MHRA application.

It will be important that you work with colleagues responsible for making the submissions to MHRA and REC to ensure the process is followed. It will not be possible for the applicant to request review by a specific REC. To ensure a streamlined process, HRA will appoint the REC to review your application.

If this is process is something that you would be interested in participating in, please inform MHRA in advance of submitting any applications by emailing CI-applications@mhra.gov.uk, and confirm the following to verify that your study is appropriate for this process:

  1. The REC application has not yet been made
  2. The study does not involve adults lacking capacity
  3. The study is not a CTIMP
  4. The estimated application date
  5. The IRAS Project ID number (if available)
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