# The Medical Devices (Northern Ireland Protocol) Regulations 2021, Regulation 17C: Ethical review of performance studies


(1) In Regulation (EU) 2017/746 a reference to an ethics committee is a reference to an ethics committee within the meaning of regulation 3(1).
(2) In relation to a performance study to which Article 58(5)(b) applies, 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 performance study starts.

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