Regulation 19 Fees payable in connection with the designation of notified bodiesI1

Fees in connection with the designation of notified bodies are set out in Schedule 2.

The applicant must pay the Secretary of State the fee specified in table 1 in Schedule 2 for an application—

A notified body designated by the Secretary of State under Article 42 F4of 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 F5£1,503.

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.

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.

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 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.

If a conformity assessment body fails to pay a fee under paragraph (6), the Secretary of State may—

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^f1.