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The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021
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- 2021 No. 910
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Amendment of the Medical Devices Regulations 2002
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3. In regulation 2(1) 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);”.
(1)
Regulation 2 has been amended on a number of occasions, most recently by S.I. 2020/1478. The definition of “clinical data” was inserted by S.I. 2008/2936.
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