# The Medical Devices (Northern Ireland Protocol) Regulations 2021, Regulation 17A: Advice in relation to intended clinical investigations


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

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Source: https://www.legislation.gov.uk/uksi/2021/905/regulation/17A (the official version)
Page: https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-17A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.