Mandatory validation of Covid-19 test kits and detection devices

24 August 2021

On 28 July 2021, legislation came into force which introduced validation for antigen and molecular Covid-19 detection tests.

The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021, made under the Medicines and Medical Devices Act 2021, require antigen and molecular Covid-19 tests to undergo mandatory desktop review to assess their performance before being permitted for sale on the UK market.

The Department of Health and Social Care (DHSC) has now issued a call for evidence asking, in particular, for information regarding the costs for individual businesses involved in the domestic Covid-19 test kit sector.

With full details available at GOV.UK (including a template for replies), this consultation will be open for comments until 16 September 2021.

The Government intends to introduce a second statutory instrument in the autumn which will add mandatory laboratory validation to the current desktop review for Covid-19 tests.

This will, it explained, ensure that any such test on the UK market meets a minimum standard — the same standards as those met by Covid-19 tests procured for the NHS.

The results of this call for evidence will help to shape the Government’s future policy and the resultant analysis will be published in the impact assessment underpinning that policy.

The Government will also publish a register of tests that have passed validation to make it easy for consumers to make informed choices about the tests they purchase.