UK MHRA · March 06, 2026

COVID-19 test approval: how to apply

MHRA guidance on the application process for manufacturers and distributors seeking UK market approval for COVID-19 test devices.

Medium impact Medical Devices UK medical-devicesivdclassificationmarket-surveillance

How manufacturers or distributors of Coronavirus (COVID-19) test devices can apply for approval of their tests to be placed on the UK market.

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Published by UK MHRA. HealthSignal links to the original document; the summary above is extracted from the source text.