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<p>There is no accreditation process which applies to the businesses supplying COVID-9
lateral flow device (LFD) tests to the National Health Service. However, COVID-19
tests must have either a CE-mark or UKCA mark and either approved under the Medical
Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 or listed
on one of the temporary protocols. Where the UK Health Security Agency (UKHSA) or
the devolved administrations procure LFD tests on behalf of the NHS, Coronavirus Test
Device Approval is not required. However, the UKHSA evaluates these tests in a laboratory
to ensure they display performance characteristics desirable for population testing.
This evaluation is performed in advance of any procurement.</p>
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