The Medical Devices (Northern Ireland Protocol) Regulations 2021

PART 4 Notified bodies designated under Regulation (EU) 2017/745

Notified bodies

18.—(1) The Secretary of State is the appointed authority responsible for notified bodies under Article 35.

(2) In the event of restriction, suspension, or withdrawal of a designation, the notified body must provide the Secretary of State with any documents requested for the purposes of enabling the Secretary of State to exercise the functions of the authority responsible for notified bodies under Article 46(6).

Fees payable in connection with the designation of notified bodies

19.—(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;

(b) for reassessment under Article 44(10);

(c) to extend the scope of a designation under Article 46(1).

(3) A notified body designated by the Secretary of State under Article 42 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 £532.

(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 £361.20 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 £90.30 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;

(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(1).

(1)

OJ No. L 212, 09.08.2012, p. 3.