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
- MHRA’s guidance about software and apps
- Is your app a medical device? It’s healthy to know: regulator issues updated guidance
- 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.