Validation of COVID-19 tests: laboratory validation
This is a public consultation on proposals to introduce mandatory laboratory validation for COVID-19 test products before entry to the UK market, under the Medicines and Medical Devices Act 2021.
On 28 July 2021, it became a legal requirement for antigen and molecular COVID-19 detection tests to undergo validation (in the form of a desktop review) to assess their performance before being permitted for sale in the UK market.
The government is consulting on proposals to deliver an additional step of laboratory validation to increase the scrutiny placed on COVID-19 test products.
In this consultation, we are seeking views on:
- desktop review
- laboratory validation and its future scope
- fees regime
- sensitivity and specificity thresholds
- sample types
- the regulatory environment
- the supply of COVID-19 tests, including trade flows
- safety, favourability and availability of COVID-19 tests
- extending the scope of validation to cover other pathogen diagnostics
This is a public consultation open to everyone.
We are keen to obtain responses from businesses from all parts of the UK and internationally involved in the manufacture, distribution and retail of COVID-19 tests as both a good and a service as well as to users of the products.
We are also keen to receive expert academic views and the views of health system professionals.
The results of this consultation will help to shape the policy.