Europe – Euro Roundup: MHRA shares guidance on coordinated assessment pathway for device trials

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the coordinated assessment pathway it is piloting to streamline the review of clinical investigations involving medical devices.

MHRA and the Health Research Authority (HRA), which makes sure research is ethically reviewed and approved, are working together to test the pathway. The two organizations are sharing information on their assessments of medical device clinical investigations. Currently, MHRA and Research Ethics Committees (RECs), which review research applications as part of the HRA approval process, are working in parallel on their assessments of applications…