S.I. No. 725/2022 - European Union (National Research Ethics Committees for Performance Studies of in Vitro Diagnostic Medical Devices) (Amendment) Regulations 2022
Notice of the making of this Statutory Instrument was published in | ||
“Iris Oifigiúil” of 3rd January, 2023. | ||
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: | ||
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. | ||
2. These Regulations shall come into operation on 1st January 2023. | ||
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). | ||
4. The following Regulation is substituted for Regulation 35 of the Principal Regulations: | ||
“Fees | ||
35. (1) The following fees shall be payable by a sponsor to the National Office: | ||
(a) €1,500 in respect of each application for National REC review relating to the conduct of a performance study in the State, | ||
(b) €300 in respect of each application for National REC review of a substantial modification of a performance study, and | ||
(c) €1,200 in respect of each appeal under Regulation 24 (which fee shall be refundable if the appeal is successful). | ||
(2) Where the National Office is satisfied that an application relates to a non-commercial performance study, at the discretion of the National Office— | ||
(a) the fee payable under paragraph (1)(a) may be reduced to €150, | ||
(b) the fee payable under paragraph (1)(b) may be reduced to €50, and | ||
(c) the fee payable under paragraph (1)(c) may be reduced to €100”. | ||
(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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GIVEN under my Official Seal, | ||
23 December, 2022. | ||
STEPHEN DONNELLY, | ||
Minister for Health. | ||
EXPLANATORY NOTE | ||
(This note is not part of the Instrument and does not purport to be a legal interpretation) | ||
These Regulations amend the European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) Regulations 2022. | ||
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. |
