# The Medical Devices (Northern Ireland Protocol) Regulations 2021, Regulation 17D: Arbitration following the refusal of a performance study application


(1) A sponsor notified of a refusal under Articles 66(3), 67(4) or 74(10) may, within 28 days of being notified, apply to the Institute to appoint an adjudicator to review the refusal.
(2) The adjudicator must provide a report to the Secretary of State and the sponsor, setting out any recommendations in respect of the disputed refusal.
(3) The Secretary of State must take the report of the adjudicator into account and decide whether to—
(a) confirm or alter the grounds for the refusal of the application,
(b) authorise the performance study, or
(c) in the case of a refusal under Article 66(3), proceed to consider the application under Article 66.
(4) The Secretary of State must notify the sponsor of the decision in paragraph (3).
(5) The sponsor must pay any fees, costs and expenses of the Institute and its appointed adjudicator that are payable in connection with the application made under paragraph (1).

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