New guidance on Medical Devices

New guidance on a new MHRA/ Health Research Authority (HRA) coordinated assessment pathway for
Medical Device Clinical Investigations has been issued (4th January 2022).

The MHRA is working with the Health Research Authority (HRA) to develop a new coordinated assessment pathway which is intended to aid the sharing of data and consequentially 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.

For this process to work, the MHRA requires the 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.

The two organisations (MHRA/HRA) will then share information and findings with one another.

To participate in this process, you must be in a position where both the MHRA Devices and REC applications have been prepared and are ready to be submitted (but have not been submitted yet).

The guidance (Guidance V1.0 Jan 2022) can be found here.