IRAS Help - Preparing & submitting applications

Help - Preparing & submitting applications - MHRA Devices

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MHRA Devices

IMPORTANT: Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials).

It is no longer possible for CTIMP or IMP/Device trial applications to be made using this part of IRAS. If you have an existing CTIMP or IMP/Device trial project and have not yet submitted, you will no longer be able to do so here.

If you are about to start a new CTIMP application, please use the guidance on the HRA website for instructions on how to apply for combined review. Users already preparing their applications via the new combined review service should login to the new part of IRAS.

If you have any queries related to applying for combined review, please contact cwow@hra.nhs.uk.

If your combined review application will involve either ionising radiation or an investigational medical device, you should also review our separate instructions in IRAS help.

Please note: These changes only apply to CTIMPs and IMP/Device trials. All Clinical investigations of a medical device only (or other study of a medical device) should continue to use this part of IRAS for applications to MHRA Devices. There is a separate pilot together to test a coordinated assessment pathway that will streamline the review of clinical investigations of medical devices. Please see the box below for more information

Co-ordinated assessment pathway for clinical investigations of medical devices: the Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are working together to test a coordinated assessment pathway that will streamline the review of clinical investigations of medical devices. To find out more and register your interest visit the MHRA website.

Research involving an in vitro diagnostic device (IVD): Currently, different EU regulation applies to studies that involve a performance evaluation of an IVD taking place in Northern Ireland compared to the rest of the UK. To find out more about these regulations and what it means for your research application we have produced some guidance to help.

Introduction

Information about applying to MHRA to conduct a clinical investigation of a medical device is provided on the MHRA's dedicated webpage.

Page last updated: 08 April 2024