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Mandatory Validation of Covid-19 Tests – Industry Update

By November 5, 2021No Comments

Applicants who submitted an application prior to the 31st August 2021, were expecting to continue to provide their tests to market until 31st October pending the approval by CDTA under The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (legislation.gov.uk)

CDTA were unable to conclude approvals within this time frame, and whilst in some cases, the quality of applicant’s submissions was an issue, the response times, clarifications, and overall resource available to complete approvals has caused the CDTA to issue an update on the 20th October 2021.

The CDTA Register and temporary protocol were published on 20th October, and a revision on the 3rd November 2021. You should check these documents (below) regularly.

CTDA register – the register lists tests that have been approved, following the CTDA desktop review process, to either remain or be placed on the market after 31 October 2021 under regulation 38A(5) of the Medical Devices Regulations 2002. It will be updated on a rolling basis as approvals take place and may be accessed here: https://www.gov.uk/government/publications/covid-19-test-validation-approved-products

Temporary protocol – the protocol to allow certain tests pending the outcome of the CTDA desktop review to continue being supplied after 31 October in the short term, subject to meeting the conditions outlined in the protocol. Annex A to this communication provides a list of tests on the temporary protocol at time of sending, with a live list accessible within the full text of the temporary protocol here: https://www.gov.uk/government/publications/covid-19-test-validation-approved-products/medical-devices-regulations-2002-protocol

A letter was also sent to Pathology Incident Directors, dated 20th October with instructions on what to do about tests that are not exempt from the CTDA requirements and not included in the temporary protocol or approved through the CTDA process.

Where there is a test that laboratories rely on which is not covered by the exemptions and is not listed on either the temporary protocol or the CTDA register, they must check the status of the CTDA application for that test with their supplier. They encourage use of alternative tests that either have been approved under the CTDA process or that are listed on the temporary protocol.

Alternatively, if a test has an application to the CTDA legislation process it could be considered for addition to the temporary protocol, if not being able to use that test might pose a serious risk to public health. The protocol is intended to be a living document where tests can be added as well as removed from the list as necessary, and where the public health risk is evidenced.

If customers are concerned about the risk to public health due to a test not being listed on the temporary protocol, they should contact validation@dhsc.gov.uk to suggest it be considered for inclusion.

On 4th November, BIVDA co-signed a letter with ABHI to Professor Jennifer Harries OBE which highlighted the issues that our members are facing and the impact on the industry, and which called for a review of the lists and extension to the grace period for applicants.

BIVDA will also be issuing a more specific letter on receipt of finalised legal advice to key stakeholders relating to the potential challenges that could be faced based on the communications issued with the temporary protocol and from CDTA if amendments are not adopted. We will be communicating on this matter via our COVID-19 Task Force distribution list. Please contact Natalie if you wish to be added.

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