Regulation 17A Advice in relation to intended clinical investigationsF1

(1)

A manufacturer or sponsor may request a meeting with the Secretary of State in advance of an application being submitted under Article 70(1) in order to—

(a)

obtain advice on regulatory requirements relating to an intended clinical investigation; or

(b)

obtain a statistical review in relation to an intended clinical investigation.

(2)

A person who requests a meeting with the Secretary of State under paragraph (1), must pay the following fees in advance of that meeting—

(a)

F2£987 for a regulatory advice meeting under paragraph (1)(a); and

(b)

F3£852 for a statistical review meeting under paragraph (1)(b).

(3)

In this regulation, “statistical review” means a review of the statistical sections of the application which a sponsor intends to submit to the Secretary of State under Article 70(1) in respect of an intended clinical investigation.

Annotations

Textual amendments

F1: Reg. 17A inserted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 21
F2: Sum in reg. 17A(2)(a) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 17(a)
F3: Sum in reg. 17A(2)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 17(b)