UK – UK regulators publish new details on streamlined medical device clinical study review program

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated guidance on clinical investigations of medical devices that includes details about the regulator’s new Coordinated Assessment Pathway pilot program for streamlined reviews of clinical trials.

According to the new guidance, the MHRA will conduct the pilot in collaboration with the UK Health Research Authority (HRA), and conduct reviews of clinical investigations in parallel with reviews carried out by the HRA’s Research Ethics Committee, with the aim of reducing overall review timeframes for medical devices entering the UK market…