Government responds to consultation regarding private COVID-19 testing validation
A Government response has been provided by the Department for Health and Social Care to the consultation regarding private COVID-19 testing validation. The public consultation opened from 8th April 2021 and closed on 5th May 2021. It proposed a requirement that all COVID-19 tests place don the UK market undergo a mandatory validation process to assess their performance, above and beyond CE marking. Please see the below points from the Response document:
- ‘Broad support’ was received by the Government regarding the policy aims in the consultation, in particular the need to implement a minimum performance standard for the tests put onto sale in the UK.
- The majority of respondents to the question agreed that the validation process should be paid for through fees rather than subsidised by the taxpayer.
- Laboratory technical validation is intended by the Government to be introduced at a later date.
- The Consultation question was posed: Should COVID-19 detection tests be validated beyond the verification and assurance provided for CE marking? Of those respondents who answered the question, 78% agreed and 22% disagreed. A total of 43 were asked the question and 14% provided no response.
- The Government has decided to limit the scope of technologies within scope of the proposed regulation to mature existing technologies that DHSC has an established validation process for.
- DHSC has discounted the option to introduce third party conformity assessment due to concerns over timing.
- The UK Health Security Agency will be the delivery body that provides and manages the validation process. The Department for Health does not believe there is a need to establish an independent body for oversight of the validation process.
- Regarding the validation being an unnecessary barrier to market entry, or repetitive as a validation process, the Government will ensure the process can use existing evidence “where our scientists are satisfied it is of sufficiently high quality to avoid any duplication and we are exploring implementing a lighter touch expedited verification process to sit as an alternative to the future laboratory validation”.
- Government is considering options that will enable it to charge a lower fee for businesses that are deemed to have previously met validation requirements through NHS procurement.
- Following a transition period, tests that fail this process would be barred from sale.
- Retailers, distributors and manufacturers of tests that attempt to sell unauthorised tests would face sanction.
After analysing the Consultation’s responses, DHSC has decided to take steps to lay a Statutory Instrument under the Medicines and Medical Devices Act 2021 (MMDA) to create a regulatory requirement for the mandatory approval of antigen and molecular diagnostic tests for COVID-19.
The response anticipates that private sector-provided testing will form a “crucial part of day-to-day testing as we move into the long-term management of COVID-19 and reopen the economy”. This will require ‘considerable expansion’ of domestic production and potentially an increase in imports to assure sufficient supply.
Please find a link to the full Government Consultation Response text here.