1 Further authorisation of Innova LFTs
I note that MHRA’s ‘authorisation of special use of DHSC COVID-19 Self-Test Kit’ dated 22 December 2020 states that “If this authorisation ends on 22/06/2021, and there continues to be a need for a further authorisation, the position will be reviewed by the MHRA and a decision taken on whether it remains in the interests of the protection of health for a further authorisation or an amendment to this authorisation to be made.”
I would be grateful if you could inform me whether MHRA has been informed of a need for a further authorisation and, if so, when it will take a decision and what evidence it will take into account to determine whether continued authorisation will protect health.
2 Use of Innova LFTs
I refer to paragraph 2 of MHRA’s ‘Authorisation of special use of DHSC COVID-19 Self-Test Kit’ dated 22 December 2020, which states: “This authorisation is solely for the use in the testing of large sections of the population to detect infection in asymptomatic individuals. We do not currently support the use of the test for a ‘test to enable’ function until we are satisfied there is evidence to support this.”
Please inform me whether MHRA has received any evidence to support use of the test for a ‘test to enable’ function and if so, please specify the evidence.
3 Changes to components of Innova LFTs
I would be grateful if you would inform me whether DHSC has informed MHRA of any changes to the components of the Innova lateral flow tests authorised on 22 December 2020. If so, kindly provide me with a copy of the information received from DHSC.
4 Performance and assessment of Innova LFTs
I see that paragraph 4 of the authorisation for the Innova lateral flow tests given to the DHSC by MHRA in December 2020 requires that “the devices are fit for the purpose intended, will work as intended in line with stated performance and have been assessed as such”. Please inform me of the intended purpose and the stated performance, and provide me with a copy of any assessment which MHRA holds.
5 Roll-out of and CE marking for Innova LFTs
Referring to the MHRA letter dated 22 December 2020, ‘Medical Devices Regulations 2002: authorisation of special use of DHSC COVID-19 self-test-kit’ (ref DEU/012/2020/003), I would be grateful if you could please provide me with a copy of
a. the distribution and roll-out plan referred to in paragraph 5; and
b. the detailed time plan for CE marking received by MHRA, or a copy of the explanation provided by the DHSC as to why it will not be seeking CE marking, as required by paragraph 9
6 Monitoring of Innova LFTs
I would be grateful if you would provide me with a copy of the information MHRA holds about the mechanisms in place for monitoring the performance of the Innova LFT devices as referred to in paragraph 11, of the authorisation for those tests given by MHRA to the DHSC on 22nd December 2020, and of the evidence which has been obtained as a result of the operation of those mechanisms.