S.I. No. 376/2026 - European Union (Clinical Investigations of Medical Devices) (National Research Ethics Committees) (Amendment) Regulations 2026 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English Produced by the Office of the Attorney General Táirgthe ag Oifig an Ard-Aighne Home Legislation Acts of the Oireachtas Statutory Instruments Pre-1922 Legislation Constitution External Resources Bills (Houses of the Oireachtas) Iris Oifigiúil / Official Gazette Revised Acts (LRC) Classified List of Legislation (LRC) Translations (acts.
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- s)or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile Statutory InstrumentsIonstraimí Reachtúla 2026 S.I. No. 376/2026 - European Union (Clinical Investigations of Medical Devices) (National Research Ethics Committees) (Amendment) Regulations 2026 S.I. No. 376/2026 - European Union (Clinical Investigations of Medical Devices) (National Research Ethics Committees) (Amendment) Regulations 2026 AmendmentsLeasuithe Download PDF Íoslódáil PDF 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. 1 OJ No. L 117, 5.5.2017, p. 1 Privacy Statement Accessibility European Legislation Identifier (PDF) Open Data License Ráiteas Príobháideachais Inrochtaineacht Aitheantóir Eorpach Reachtaíochta (ELI) Ceadúnas Sonraí Oscailte Liosta Fianán © Government of Ireland. Oireachtas Copyright Material is reproduced with the permission of the Houses of the Oireachtas © Rialtas na hÉireann. Atáirgtear ábhar faoi Chóipcheart le cead ó Thithe an Oireachtais