Skip to main content

The Medical Devices (Coronavirus Test Device Authorisations) (Amendment) Regulations 2021

Statement made on 17 June 2021

Statement UIN HCWS97

Statement

Testing will remain important to controlling and containing the virus going forward. We will need a reliable supply of high quality tests available to give people and businesses the confidence to go about their usual activities.

Consumers should have clear comparable information so they can cut through any confusion in a rapidly growing market for COVID-19 tests and buy with confidence. People need to know the tests they buy will be as good as those they would receive through the NHS and that they can trust the results they get in order to manage their behaviour accordingly.

The Statutory Instrument we are laying today will establish a regulatory regime by which this Government will ensure all tests on the UK market meet minimum standards of sensitivity and specificity. The regulations allow us to build a framework to validate all antigen and molecular tests sold in the UK market to the same high standards established for government-procured tests.

We will establish a clear process for manufacturers to get their test onto the market as quickly and easily as possible, giving consumers assurance of test accuracy. We have set in these regulations performance thresholds that will provide robust criteria for industry to meet when putting their tests on the UK market.

We will publish a register of tests that have passed their validation along with other appropriate information about them. This will be set in a clear and comparable way for each test. Consequently, test users may thereafter be in a position to make prudent choices when buying kits tand individual consumers are empowered.

We intend for this regime to recover its costs primarily from manufacturers rather than be supported by taxpayers. This point was agreed by the majority of respondents, during a public consultation, . However, we are also conscious of concerns raised during the consultation that if fees are set too high, it could present a barrier to SME manufacturers entering the market. In response, we have included a discounted fee for such businesses so that they are not blocked from bringing new tests to market.

In order to balance the need to give industry reasonable time against the need to remedy market failure, the instrument includes a grace period to enable tests to continue to be supplied whilst they complete the validation process. This will mean any test already on the market will be able to remain so as long as their manufacturers adhere to the new requirements. They will have until the 1st September to apply for the validation process. They will then have until 31st October to pass validation. A test that fails validation, will need to be removed from the market.

We are confident this regulation is a proportionate and appropriate measure to ensure that all COVID-19 tests available across the UK meet the standards this validation process will establish.

Protecting public health is my overriding concern. We have thus first and foremost considered what impacts potentially bringing a regulatory regime for validation of COVID-19 tests will have on public health, as well as the safety of the tests themselves, their availability, and the likelihood of the UK being seen as a favourable place to carry out research on, develop and manufacture COVID-19 tests. In all these regards we believe this regulation will have a positive impact on the quality, safety, and supply of high quality COVID-19 detection tests.

We will also place the draft of the guidance document for manufacturers in the House Libraries of Both Houses’ to support colleagues in their scrutiny of the Statutory Instrument. We will also lay before the debate the Impact Assessment to further support colleagues in their scrutiny function.

Linked statements

This statement has also been made in the House of Lords

Department of Health and Social Care
The Medical Devices (Coronavirus Test Device Authorisations) (Amendment) Regulations 2021
Lord Bethell
Parliamentary Under Secretary of State (Minister for Innovation)
Conservative, Excepted Hereditary
Statement made 17 June 2021
HLWS92
Lords