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.
Other helpful resources
- Is your app a medical device? MHRA’s guidance on what a software application medical device is and how to comply with the legal requirements
- Notify the MHRA about a clinical investigation for a medical device
- MHRA guidance on the regulation of device investigations
- The HRA provides a free eLearning module on regulations and considerations for clinical investigations or other research studies of medical devices across the UK.