Coronavirus Test Device Approval

Maggie Throup Excerpts

Thursday 24th February 2022 Written Statements

[The Parliamentary Under-Secretary of State for Health and Social Care (Maggie Throup)]

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

I have been impressed by the number of applications that the validation process has received to date. This figure currently stands at 212 applications across all antigen and molecular test devices. 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.

In order to ensure the greatest possible number of high-quality tests are available to the public, we have worked closely with applicants to support them through the process, which inevitably slows the validation process overall. As of 24 February 2022, 31 devices are on the approved products list and officials continue to work closely with applicants to support them through the process.

To avoid the serious public health risk posed by a shortage of covid-19 tests, I exercised my power under regulation 39A of the Medical Devices Regulations 2002 to permit certain tests with a pending application to remain on the market up to 28 February 2022, or until their validation application is determined, as a temporary protocol.

With the current end date of the protocol being 28 February 2022, this means some useful devices would have to be temporarily removed from the market while they complete their validation under the CTDA process. This will likely create a contraction in supply to the market, particularly of self-test lateral flow devices. This presents a serious risk to supply chains and testing used by vulnerable people. Therefore, the creation of two new protocols is needed to address the public health risks presented by the ending of the current protocol, otherwise, these devices would be removed from the UK market.

From 1 March 2022, I am now intending to create two new protocols, one for three months for certain devices until 31 May 2022 and one for six months until 31 August 2022. These new protocols would replace the current protocol which expires on 28 February 2022.

The tests that are permitted to remain on the market with a pending validation application are listed in the protocol on gov.uk. These tests have been selected because they have been through similar validation previously by a public sector body and have an existing CTDA application. There is, therefore, a reasonable expectation that the performance of these tests can be trusted to protect the public from the risk posed by false results.

I have placed copies of both protocols in the Libraries of each House of Parliament and they have been published on the gov.uk website.

[HCWS637]