# The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020, Regulation 4: Test requirements

Extent: E+W

(1) Any device used for the purposes of an applicable test must meet the following requirements—
(a) it can be put into service in accordance with Part 4 of the Medical Devices Regulations 2002 , other than solely by virtue of regulation 39(2) of those Regulations;
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(3) In this regulation—
(a) “device” means an in vitro diagnostic medical device within the meaning given in regulation 2(1) of the Medical Devices Regulations 2002;
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/uksi/2020/1549/regulation/4 (the official version)
Page: https://openlegislation.uk/health-protection-coronavirus-testing-requirements-and-standards-england-regulations-2020/regulation-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.