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.

Coordinated Assessment Pathway pilot criteria

Medical device manufacturers interested in participating in the Coordinated Assessment Pathway pilot must meet the following criteria:

• Email the MHRA with “MHRA/HRA Coordinated assessment pathway pilot” in the subject line explaining interest in participation;
• Participants’ lead clinical investigation sites should be located in England;
• Participants should contact MHRA before submitting any materials to MHRA or HRA.

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.

Learn more about UK MHRA medical device regulations and clinical research at Emergo by UL:

• UKRP and Brexit transition consulting for medical device companies
• European MDR, IVDR and ISO 14155 clinical compliance consulting
• Post-market clinical follow-up (PMCF) studies for medical devices