The Medical Devices Regulations 2002

Waivers, reductions and refunds

58.—(1) The Secretary of State may—

(a) waive payment of any fee or reduce any fee or part of a fee otherwise payable under this Part;

(b) refund the whole or part of any fee paid pursuant to this Part.

(2) Without prejudice to the generality of paragraph (1), where—

(a) a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) is withdrawn within the period of 7 days beginning with the date of its receipt by the Secretary of State; or

(b) an application for designation as—

(i) a notified body under regulation 45(1), or

(ii) an EC CAB under regulation 48(1),

(other than one submitted only to address the grounds of rejection of a previous application) is withdrawn within the period of 21 days beginning with the date of its receipt by the Secretary of State,

• the fee payable shall be reduced to fifty per cent of the fee otherwise payable in respect of such notice or application, and any excess already paid shall be refunded.