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The Medical Devices (Northern Ireland Protocol) Regulations 2021
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This is a draft item of legislation. This draft has since been made as a UK Statutory Instrument: The Medical Devices (Northern Ireland Protocol) Regulations 2021 No. 905
Ethical review of clinical investigations
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11.—(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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