Medical devices and software applications

Last updated on 12 Jun 2023

Under the Medical Devices Regulations, ethical approval is required for a clinical investigation undertaken by, or with the support of, the manufacturer or another commercial company in order to demonstrate the safety and performance of a non-UKCA/CE UKNI/CE-marked medical device, or a UKCA/CE UKNI/CE-marked device that has been modified or is to be used for a new purpose. 

This requirement applies to the whole of the UK. Ethical approval for the purposes of the Medical Devices Regulations must be given by a Research Ethics Committee (REC) within the UK Health Departments’ Research Ethics Service (RES)

It is strongly recommended that application is made to a flagged REC for medical devices research. 

Coordinated assessment pathway

In partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), we can offer a new coordinated assessment for clinical investigations involving medical devices.

Research teams submit the MHRA Devices application first and once it is confirmed as valid, submit the REC application.

The MHRA and REC reviews are then done in parallel with our two organisations sharing information during the assessment process.

To see more information and find out how to participate, head over to the MHRA website.

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