Do you need help navigating regulatory requirements for a medical device?
In December 2025, we launched the new MHRA Regulatory Advice Service for medical devices, offering those developing and working with medical devices the opportunity to meet directly with the MHRA regulatory experts.
Since its launch, we have helped companies developing, manufacturing, marketing or distributing medical devices or in vitro diagnostic (IVD) devices understand how UK requirements apply to their specific products.
The service is particularly beneficial for cross-cutting technologies and novel products that have the potential to significantly improve patient outcomes, helping to identify and address regulatory considerations early. Think AI-enabled diagnostics, novel genetic tests and medical device apps to help patients manage their health.
Case study: Virax BiolabsIn February 2026, we held a regulatory advice meeting with Virax Biolabs, a biotechnology company developing a first-of-its-kind IVD test for immune dysfunction in post-acute infection syndromes such as post-acute COVID-19 (also known as long COVID).The company was looking for guidance on how to best establish their intended use statement and validation approach where a reference standard was not available.The MHRA experts provided advice on:
how to formulate the intended use for the device, how to apply the future IVD classification system, the regulatory submission pathway for the test and the analytical and clinical validation plans.We asked Dr. Nigel McCracken, Chief Operating Officer at Virax Biolabs what advice they would give other companies considering the MHRA regulatory advice service for medical devices:
“Developing diagnostics or medical devices is a journey where time and efficiency is extremely important […]. There is now a vehicle to request and engage in dialogue with the MHRA where the timelines for obtaining a meeting and receiving written feedback are short. Relevant regulatory feedback is extremely important and helpful and the MHRA regulatory advice meeting is a good vehicle to achieve such information.”
Requesting a meetingYou can find more information on the regulatory advice service, including how to request a meeting: Medical devices: ask for a regulatory advice meeting from the MHRA
Other MHRA advisory servicesThis service complements the advice provided by other teams in the agency, including:
Clinical Investigations – advice meeting specifically for clinical investigation of medical devices, not IVDs Scientific advice for medicines – scientific advice meetings about medicines, not medical devices or IVDs. Contact usFor more information on our regulatory advice service for medical devices, email: Devices.RegulatoryAdvice@MHRA.gov.uk
Tags: Diagnostics, Improving Our Services, Innovation, IVD, Medical Devices
seen at 14:38, 21 September in MedRegs.