Under regulation 34A of the Medical Devices Regulations 2002 no antigen or molecular detection COVID-19 (SARS-CoV-2) test may be placed on the UK market without first being validated against minimum performance standards through a Coronavirus Test Device Approvals desktop review. Persons wishing to supply, put into service or place on the UK market a coronavirus test device, need to apply to the UK’s Health Security Agency (UKHSA) for approval. Registration applications for covid test devices will not be accepted by the MHRA until the devices have received CTDA approval or are placed onto the Temporary Protocol list. Manufacturers of covid test devices are advised to seek CTDA approval from UKHSA prior to registering their covid test device with MHRA. If you believe your device is exempt from the regulation and wish to register it with MHRA, it is probable you will be contacted to specify the exemption applicable in The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 before your MHRA registration application is accepted. Learn about how to apply for CTDA approval: COVID-19 test approval: how to apply - GOV.UK (www.gov.uk) View COVID-19 test validation approved products here: Guidance overview: COVID-19 test validation approved products - GOV.UK (www.gov.uk) For further information about CTDA, please contact ctda@dhsc.gov.uk You can apply to register your device with the MHRA when your device is compliant with The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021