# The Medical Devices (Northern Ireland Protocol) Regulations 2021, Regulation 11: Ethical review of clinical investigations


(1) A sponsor proposing to conduct a clinical investigation of a device in Northern Ireland must apply to an ethics committee for an ethical review of the proposed clinical investigation.
(2) The sponsor must submit to the Secretary of State a copy of the opinion of the ethics committee as soon as it becomes available and before the clinical investigation is started.

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Source: https://www.legislation.gov.uk/ukdsi/2021/9780348224740/regulation/11 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.