Updated guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) on clinical investigations of medical devices covers the specifics of the coordinated assessment pathway pilot along with new information on gaining approval.
This pilot program is a collaboration between the MHRA and the Health Research Authority (HRA) designed to improve the review of clinical investigations involving medical devices. This will involve the sharing of information between the MHRA Medical Devices review and the Research Ethics Committee (REC) review which will be conducted in parallel with one another.
For manufacturers, there will be no change to the application process. To be considered for inclusion in the pilot, they must first email Devices.Regulatory@mhra.gov.uk with the subject “MHRA/HRA Coordinated assessment pathway pilot” prior to submitting any applications to either the MHRA or the REC. The guidance also lists certain exclusion criteria for investigations:
- Where the lead site is outside of England
- Which involve participants who lack adult capacity
- That are a combined trial of an investigational medicinal product and an investigational medical device
The final update to the guidance concerns approval from the HRA and Health and Care Research Wales (RCW). This approval is required for all project-based research occurring in the NHS in England and Wales and harmonises the legal compliance assessments of a trial conducted by the HRA and HRCW with those of the REC. In this way, the need for local checks of legal compliance by each individual participating organisation in England and Wales is removed and the process becomes more streamlined.
To view the full guidance document, click here.