The Medical Devices Regulations 2002

[F1Fees in connection with approval of coronavirus test devicesE+W+S

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.]