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Medical devices and software applications

Last updated on 3 Feb 2021

Under the Medical Devices Regulations 2002, 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 pilot

The HRA is working with the Medicines Healthcare products Regulatory Agency (MHRA) to pilot a new coordinated assessment pathway, which will streamline the review of clinical investigations involving medical devices. Further information is available on the MHRA website.

Other helpful resources 

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