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Coronavirus Test Device Approval Update

Volume 701: debated on Monday 18 October 2021

The UK is developing one of the most rigorous regulatory regimes in the world for coronavirus tests. The CTDA regulations have set high bars of specificity and sensitivity to ensure only high quality tests are available on the UK market. The CTDA regulations have set high bars of specificity and sensitivity to ensure only high quality tests are available on the UK market.

The Secretary of State and I have been impressed by the number of applications the regulator has received. This is a testament to the willingness of businesses to rise to the public health challenges set by this pandemic. However, some manufacturers have struggled to provide sufficient evidence in time. As things stand, this would mean they would have to be temporarily removed from the market whilst they complete their validation. This would create an unexpected contraction in supply at the start of winter. This could be particularly problematic for testing returning travellers.

In order to protect public health by ensuring availability of tests, the Secretary of State has decided to exercise the power under regulation 39A of the Medical Devices Regulations 2002. He will publish a protocol today listing certain tests that have both passed a public sector validation, and have a pending application awaiting validation, to remain on the market up to 28 February 2022 or until their validation application is determined. This protocol is a short-term, proportionate and targeted measure to minimise a risk of serious harm to public health by ensuring that a supply of tests most likely to be of high quality, having passed validation as part of DHSC procurement or other public sector process, remain on the market on an interim basis.

Copies of the protocol will also be deposited in the Libraries of both Houses and it will be published on the gov.uk website.

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