Notify the MHRA about a Clinical Investigation for a Medical Device

On 4 January 2022 the MHRA updated the guidance on how to inform them of a clinical investigation of medical devices.

The MHRA is working with the Health Research Authority (HRA) to develop a new coordinated assessment pathway which will streamline the review of clinical investigations involving medical devices.

During this phase of testing the MHRA Medical Devices review and the Research Ethics Committee (REC) review are being completed in parallel and information will be shared.

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