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Notice of the making of this Statutory Instrument was published in
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“Iris Oifigiúil” of 3rd January, 2023.
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The Minister for Health, in exercise of the powers conferred on him by
section 3
of the
European Communities Act 1972
(No. 27 of 1972) and for the purpose of giving further effect to Regulation EU 2017/746 of the European Parliament and of the Council of 5 April 2017, as amended by Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022, hereby makes the following regulations:
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1. These Regulations may be cited as the European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2022.
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2. These Regulations shall come into operation on 1st January 2023.
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3. In these Regulations “Principal Regulations” means the European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) Regulations 2022 (S.I. 257 of 2022).
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4. The following Regulation is substituted for Regulation 35 of the Principal Regulations:
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“Fees
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35. (1) The following fees shall be payable by a sponsor to the National Office:
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(a) €1,500 in respect of each application for National REC review relating to the conduct of a performance study in the State,
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(b) €300 in respect of each application for National REC review of a substantial modification of a performance study, and
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(c) €1,200 in respect of each appeal under Regulation 24 (which fee shall be refundable if the appeal is successful).
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(2) Where the National Office is satisfied that an application relates to a non-commercial performance study, at the discretion of the National Office—
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(a) the fee payable under paragraph (1)(a) may be reduced to €150,
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(b) the fee payable under paragraph (1)(b) may be reduced to €50, and
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(c) the fee payable under paragraph (1)(c) may be reduced to €100”.
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(3) The National Office may recover, as a simple contract debt in any court of competent jurisdiction, from the person by whom it is payable, any amount due and owing to it as a fee payable under this Regulation.”.
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![http://www.irishstatutebook.ie/images/ls](http://www.irishstatutebook.ie/images/ls)
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GIVEN under my Official Seal,
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23 December, 2022.
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STEPHEN DONNELLY,
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Minister for Health.
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EXPLANATORY NOTE
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(This note is not part of the Instrument and does not purport to be a legal interpretation)
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These Regulations amend the European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) Regulations 2022.
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These amend the amount of fess payable in respect of applications for National Research Ethics Committee (“National REC”) review of a performance study to be conducted in the State or for a National REC review of a substantial modification of a performance study and appeals in respect of such applications.
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