# The Medical Devices (Northern Ireland Protocol) Regulations 2021, Regulation 19: Fees payable in connection with the designation of notified bodies

Extent: E+W+S+N.I.

(1) Fees in connection with the designation of notified bodies are set out in Schedule 2.
(2) The applicant must pay the Secretary of State the fee specified in table 1 in Schedule 2 for an application—
(a) for initial designation as a notified body under Article 38 of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746;
(b) for reassessment under Article 44(10) of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746;
(c) to extend the scope of a designation under Article 46(1) of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746.
(3) A notified body designated by the Secretary of State under Article 42 of Regulation (EU) 2017/745 that submits a summary evaluation report to the Secretary of State in accordance with Article 5(4) of Regulation (EU) 722/2012, must pay to the Secretary of State a fee of £1,503.
(4) A fee specified in table 1 in Schedule 2 or paragraph (3) is payable when the application or submission to which it relates is made to the Secretary of State.
(5) If an applicant fails to pay a fee specified in table 1 in Schedule 2 or paragraph (3), the Secretary of State may reject the application or submission to which it relates.
(6) If the Secretary of State conducts an assessment or review listed in table 2 in Schedule 2, the fee payable by the conformity assessment body is—
(a) the fee specified for that assessment or review in table 2 in Schedule 2,
(b) an amount for time spent by each member of staff to undertake the assessment or review at a rate—
(i) for the time spent on site, of £732 per half day (period of less than a half day counting as a half day) up to a maximum of 2 half days on any one date, and
(ii) for the time spent travelling to and from the site, of £198 per hour,
(c) the actual costs of travel, accommodation and subsistence, and
(d) out of pocket expenses.
(7) A fee under paragraph (6) is payable within one month of receipt by the conformity assessment body of a written notice from the Secretary of State requiring payment of the fee.
(8) If a conformity assessment body fails to pay a fee under paragraph (6), the Secretary of State may—
(a) refuse to designate the body under Article 42 of Regulation (EU) 2017/745 or Article 38 of Regulation (EU) 2017/746;
(b) if the body has already been designated, suspend, restrict, or fully or partially withdraw, the designation.
(9) In this regulation, “Regulation (EU) 722/2012” means Commission Regulation (EU) No 722/2012 of 8th August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin.

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Source: https://www.legislation.gov.uk/uksi/2021/905/regulation/19 (the official version)
Page: https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-19
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.