# The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021, Regulation 3: Amendment of the Medical Devices Regulations 2002


In regulation 2 after the definition of “clinical data”, insert—
““coronavirus test device” means an in vitro diagnostic medical device for the detection of the presence of a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);”.

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Source: https://www.legislation.gov.uk/ukdsi/2021/9780348224795/regulation/3 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-coronavirus-test-device-approvals-amendment-regulations-2021/regulation-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.