The UK Health Security Agency (UKHSA) has validated a number of COVID-19 test devices, under Regulation 38A(5) of the Medical Devices Regulations 2002.
Following a review of COVID-19 test providers accredited by UKAS, it has come to our attention that a number of providers are accredited for services using one or more assays or test devices which are not currently on the list of approved devices. By law all COVID-19 tests being supplied and put into service by private providers must have been approved under the Coronavirus Test Device Approvals (CTDA) legislation. The list of approved devices is available here.
If your UKAS accreditation only includes CTDA-approved assays or test devices, this letter is for information only, and you do not need to take any action.
If your UKAS accreditation includes one or more non-approved assays or test devices, we will write to you before the 31 July 2022 to inform you that accreditation for the non-approved assays or test devices will be suspended. If the assay or test device is subsequently approved then accreditation will be reinstated. Otherwise the suspension will remain in place for a period of up to nine months. Following this suspension period, if the assay or test device is still not on the list of approved COVID-19 test devices, accreditation may be withdrawn.
If the assay or test device in use is added to the list of approved devices after accreditation has been suspended, please contact your UKAS assessment manager, with evidence of the updated list, who will then take steps to reinstate your accreditation.
If you have any queries about the COVID-19 test validation approval process or list, please contact UKHSA CTDA team.
If you have any queries about UKAS accreditation, please contact your assessment manager.