Feb 10, 2021
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.
Medical device manufacturers interested in participating in the Coordinated Assessment Pathway pilot must meet the following criteria:
During the initial phase of the pilot, clinical investigations involving adult subjects lacking capacity do not qualify for participation; investigations comprising combined trails of investigational medicinal and medical device products are also excluded from participation.
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