# The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 28: Substitution of regulation 5(5)


For regulation 5(5) substitute—
“(5) In regulation 26 (exemptions from regulations 22 and 24)—
(a) in paragraph (1) omit “Directive 90/385 or”;
(b) in paragraph (3) for “CE marking” substitute “UK marking”;
(c) after paragraph (3) insert—
“(4) Regulations 22 and 24 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards or which is marked other than with a UK marking which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 22 and 24, may be placed on the market.
(5) In paragraph (4), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 22 and 24, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348214956/schedule/2/paragraph/28 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-28
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.