# The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021, Regulation 9: Amendment of the Medical Devices Regulations 2002


After regulation 56 (fees payable in relation to clinical investigation bodies) insert—
“Fees in connection with approval of coronavirus test devices
56A. (1) A person who makes an application to the Secretary of State under regulation 38A(1) must pay to the Secretary of State a fee of—
(a) £14,000; or
(b) if the person is a small or medium-sized enterprise, £6,200.
(2) Where the Secretary of State, in accordance with regulation 38A(4), treats an application made before the coming into force of regulation 38A as an application made under that regulation, a payment made in respect of that application before the coming into force of this regulation must be treated as—
(a) a payment meeting the requirements of paragraph (1), if that payment would have met those requirements after their coming into force; or
(b) a payment contributing in part to the payment required by paragraph (1), if that payment would not have met those requirements after their coming into force.
(3) In this regulation—
(a) a person is a small or medium-sized enterprise if it and persons associated with it employ no more than 250 individuals in total; and
(b) “persons associated with it” has the same meaning as in section 882 of the Corporation Tax Act 2010.”.

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Source: https://www.legislation.gov.uk/ukdsi/2021/9780348224795/regulation/9 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-coronavirus-test-device-approvals-amendment-regulations-2021/regulation-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.