S.I. No. 26/2026 - European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2026

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 3rd February, 2026.

I, JENNIFER CARROLL MACNEILL, Minister for Health, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving further effect to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 and Regulation (EU) 607/2023 of the European Parliament and of the Council of 15 March 2023, hereby make 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 2026.

2. These Regulations shall come into operation on 1 February 2026.

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 Principal Regulations are amended by deleting Regulation 35, and substituting it with the following:

‘Fees

35. (1) Subject to paragraph (2), the following fees shall be payable by a sponsor to the National Office:

(a) €1650 in respect of each application for National REC review relating to the conduct of a performance study in the State,

(b) €440 in respect of each application for National REC review of a substantial modification of a performance study, and

(c) €2000 in respect of each appeal under Regulation 24 (which fee shall be refundable if the appeal is successful).

(2) Paragraph (1) does not apply to applications relating to a non-commercial performance studies.

(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.”.

5. The European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2023 ( S.I. No. 670 of 2023 ) are revoked.

GIVEN under my Official Seal,

29 January, 2026.

JENNIFER CARROLL MACNEILL,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the instrument and does not purport to be a legal instrument.)

These Regulations amend the European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) Regulations 2022.

These Regulations also revoke European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2023 ( S.I. No. 670 of 2023 ).

They amend the amount of fees 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.