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Medical devices and software applications

Last updated on 19 Mar 2018

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-CE marked medical device, or a 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. 

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