reg 54 Fees payable in connection with the designation of approved bodies
(1) A corporate or other body that applies to the Secretary of State for designation under regulation 45 as an approved body shall, in connection with that application for designation, pay to the Secretary of State— (a) if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of £10,335 ; or (b) in all other cases, a fee of £41,337 . (2) A corporate or other body that applies to the Secretary of State for a variation under regulation 45(4) must, in connection with that application for a variation, pay to the Secretary of State— (a) in respect of an extension to the scope of the body’s designation to carry out tasks under Part 2, Part 3 or Part 4, which extends the body’s designation in relation to a Part under which they have already been designated, a fee of £14,568 ; (b) in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and where the Secretary of State considers that an additional assessment of the body’s procedures is required, a fee of £21,105 . (3) Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, both read with Regulation ( EU ) No 722/2012 or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State— (a) in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of £67,606 plus the amounts specified in paragraph (3A); (b) in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection, a fee of £52,929 , plus the amounts specified in paragraph (3A); and (c) in respect of an inspection pursuant to regulation 45(7)(b), a fee of £11,672 plus the amounts specified in paragraph (3A). (3A) Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be— (a) an amount for time spent by a member of staff undertaking a site visit at a rate— (i) for the time spent on site, of £732 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and (ii) for the time spent travelling to and from the site, of £198 per hour; (b) the actual costs of travel, accommodation and subsistence; and (c) out of pocket expenses. (3B) Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)— (a) the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and (b) the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a). (3C) An approved body that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation ( EU ) No 920/2013 shall pay to the Secretary of State— (a) a fee of £41,337 in respect of the application; and (b) where an audit is carried out in connection with the application, a fee of £67,606 in respect of the audit , plus the amounts specified in paragraph (3A). (3D) Where the Secretary of State conducts an assessment of an approved body pursuant to article 5 of Regulation ( EU ) No 920/2013, the approved body shall pay to the Secretary of State— (a) if the assessment relates to the UK notified body’s assessment of clinical data only, a fee of £21,535 ; or (b) in any other case, a fee of £26,408 , plus the amounts specified in paragraph (3A). (3E) An approved body that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation ( EU ) No 722/2012 shall pay to the Secretary of State a fee of £1,503 . (3F) Where, pursuant to regulation 45(7)(a) or 45(7)(b), the Secretary of State conducts an on-site assessment of a subsidiary of the body, the body must pay to the Secretary of State a fee of £26,408 , plus the costs and expenses referred to in paragraph (3A). (4) A fee under this regulation— (a) in connection with an application for designation under regulation 45(1), a variation under regulation 45(4) , a renewal under Regulation ( EU ) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation ( EU ) No 722/2012 — (i) shall be payable when the application or submission to the Secretary of State is made, and (ii) shall accompany the application or submission when it is made; (b) in connection with an inspection pursuant to regulation 45(7) or an audit or assessment pursuant to Regulation ( EU ) No 920/2013 , shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee. (5) In this regulation— “ Regulation (EU) No 920/2013 ” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices; and “ subsidiary ” is to be construed in accordance with section 1159 of the Companies Act 2006.