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The UK Coronavirus Test Device Approvals function is currently managed by UKHSA. The MHRA will take over this function from 24 May 2023. A guidance confirming the changes to process management will be published by the MHRA on 24 May.

The MHRA have provided the following information:

The UK Coronavirus Test Device Approvals regulatory regime is one of the most rigorous in the world for coronavirus tests. The regulations were designed to drive up performance standards, reduce the risks of false test results and support consumer confidence.

From 24 May 2023 the Medicines and Healthcare products Regulatory Agency (MHRA) will take over management of the function from UKHSA.

Manufacturers can be reassured that every effort is being made to ensure minimal disruption to the CTDA function through the transition. We will publish guidance confirming the changes to process management on 24 May, but can confirm the customer experience in the application process to remain unchanged initially, though amendments will increase as the new UK In Vitro Diagnostic (IVD) regulations enter into force. Applicants will still be required to provide MHRA with the same data currently requested on submission for CTDA.

Testing continues to play a role in managing COVID-19 and represents a key part of the UK Government’s Living with COVID plan. Through the transition MHRA will continue to ensure that tests available on the private market and for NHS staff meet high standards to empower consumers to make decisions about their own health needs. The public can have every confidence in our robust standards for quality, safety and efficacy.

For any enquiries, please contact: