LegalizeS.I. No. 376/2026 - European Union (Clinical Investigations of Medical Devices) (National Research Ethics Committees) (Amendment) Regulations 2026
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
Notice of the making of this Statutory Instrument was published in
“Iris Oifigiúil” of 31st July, 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 full effect to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 20171 hereby make the following regulations:
1.
These Regulations may be cited as the European Union (Clinical Investigations of Medical Devices) (National Research Ethics Committees) (Amendment) Regulations 2026.
2.
Regulation 17(4) of the European Union (National Research Ethics Committees for Clinical Investigations of Medical Devices) Regulations 2023 ( S.I. No. 671 of 2023 ) is amended:
- (a) in subparagraph (r), by substituting “subparagraph (k);” for “subparagraph (k).”, and
- (b) by inserting after subparagraph (r) the following:
- “(s) the arrangements for clinical investigations of medical devices involving medical exposure to ionising radiation by investigation subjects, in compliance with Regulation 8(2) of the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 ( S.I. No. 256 of 2018 ).”.
GIVEN under my Official Seal,
22 July, 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 interpretation.)
These Regulations enable the National Research Ethics Committees for Clinical Investigations of Medical Devices to review and approve studies for the purposes of Regulation 8(2) of S.I. 256/2018.
Footnotes
OJ No. L 117, 5.5.2017, p. 1
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