We thought we would re iterate the Government guidance on manufactoring of lateral flow tests.

Firstly;

The regulation 34A of the Medical Devices Regulations 2002 states:

No Latetal Flow test or molecular (PCR) detection COVID-19 (SARS-CoV-2) test may be entered on the UK market without first being validated against minimum performance standards through a Coronavirus Test Device Approvals desktop review.

Campanies wishing to supply testes, put into service or place on the UK market a Covid 19 test device, first need to apply to the UK’s Health Security Agency (UKHSA) for approval.

Registration applications for covid lateral flow tests and PCR tests will not be accepted by the MHRA until the devices have received CTDA approval or are placed onto the Temporary Protocol list.

Firstly, manufacturers of lateral flow tests and PCR tests are advised to look for CTDA approval from UKHSA prior to registrating the lateral flow tests with the MHRA.

What happens if you think there is an exemption from the regulation and you want to register directly with the MHRA:

You may bbe contacted to specify the exemption applicable in The Medical Devices (Coronavirus Test Device Approvals)

(Amendment) Regulations 2021 before your MHRA registration application is accepted.

See here to what test have been approved. https://www.gov.uk/government/publications/covid-19-test-validation-approved-products

What are Target Product Profiles:

Target Product Profiles (TPPs) are designed to help producers and designers to deliver tests that might be useful in delivering the UK testing strategy.

TPPs assist the buying decisions.

If the lateral flow tests or other tests do not meet the criteria set out in the TPP does not necessarily mean that the test doesn’t have wider applications for use in the UK.

TPPs are designed witn the best information at hand.

However, science is moving and evolving fast.

The TPP is subject to review and may need to be updated at short notice.