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MHRA - New Section added to Guidance on Registering medical devices to place on the market

3rd August 2022

Coronavirus Test Device Approval (CTDA) and Registering with MHRA

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 Coronavirus Test Device Approval (CTDA) or are placed onto the Temporary Protocol list. If you believe your Covid test device is exempt from the approval requirements and wish to register it with MHRA, it is probable you will be contacted to specify the exemption applicable under the Medical Devices Regulations 2002 (as amended by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 before your MHRA registration application is accepted.

For full details see For industry and manufacturers: COVID-19 tests and testing kits

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