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Regulation 3 Amendment of the Medical Devices Regulations 2002

Original text. Later amendments are not shown.

In regulation 2f1 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);”.

Annotations

Footnotes

f1

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.