Coronavirus Test Device Approvals (CTDA): call for evidence
Call for evidence description
On 28 July 2021, legislation came into force which introduced validation for antigen and molecular coronavirus (COVID-19) detection tests. The statutory instrument made under the Medicines and Medical Devices Act 2021 requires antigen and molecular COVID-19 tests to undergo mandatory desktop review to assess their performance before being put into service, supplied, and permitted for sale on the UK market.
This call for evidence aims to support our understanding of the impact the Coronavirus Test Device Approval (CTDA) process has had on the wider internal market, individual business and trade flow of antigen and molecular COVID-19 detection tests. This will support the wider statutory review of the policy that will be reported on by 31 December 2022.