Freedom of Information request on the planned date for withdrawing emergency use authorisation of RT-PCR test for diagnosis of COIVD-19 infection in the United Kingdom (FOI 22/164)
Published 1 June 2022
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FOI 22/164
11th March 2022
Dear
Firstly please let me apologise for the delay in responding to your enquiry dated 20 January 2022. This appears to have been a completely unintentional oversight and the enquiry not forwarded to correct department to handle.
You asked MHRA to provide the following information:
-
- Planned date for withdrawing emergency use authorisation of RT-PCR test for diagnosis of COIVD-19 infection in the United Kingdom. The test is currently in use in England and in the devolved administrations [Wales, Scotland and Northern Ireland]
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- Brief details [product information sheet] of the new diagnostic test for COVID-19 infection to be used in England and the devolved administrations, following the announcement by US-FDA on 19 July 2021.
I can confirm that there are currently no RT-PCR tests which are subject to Exceptional Use Authorisation (EUA) by MHRA in the UK.
RT-PCR tests for COVID-19 diagnosis are still in use in laboratories across the UK for diagnosis of COVID-19. EUAs are no longer required as the manufacturers of these tests have now met the appropriate regulatory requirements for placing these devices on the market in the UK. This means that not only must the devices meet the requirements of UK MDR 2002 (as amended) but also the requirements of Coronavirus Testing Device Authorisation (CTDA).
Please see this link for further information about the regulatory requirements for test manufacturers including the CTDA process.
You can view a list of COVID-19 tests which meet the requirements for use in the UK via this link: Guidance overview: COVID-19 test validation approved products - GOV.UK (www.gov.uk)
MHRA does not hold the details or product information sheets for each of these tests. The manufacturers of the test may release this information on request or you may be able to obtain information sheets or other materials from the companies’ websites.
MHRA has published a range of information on Coronavirus testing for patients, the public, manufacturers and testing service providers on our website.
If you have a query about the information provided, please reply to this email.
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
I hope this information is useful and once again I apologise for the delay in our response.
Yours sincerely
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000