S.I. No. 280/2025 - European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) (Amendment) (No. 2) Regulations 2025

Type Statutory Instrument
Publication 2025-07-04
State In force
Text As published
articles 3

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.

Reform history JSON API

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 4th July, 2025.

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 Directive (EU) 2013/59/EURATOM of 5 December 20131 , as affected by Corrigendum of 17 March 20162 and Corrigendum of 11 June 20193 , insofar as it relates to medical exposures, hereby make the following regulations:

1.

1.

(1) These Regulations may be cited as the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) (Amendment) (No. 2) Regulations 2025.

2.

2.

In these Regulations “Principal Regulations” means 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 ).

3.

3.

Regulation 8(5) of the Principal Regulations is substituted by the following:

  • “(5) An undertaking shall ensure that, in the case of a medical radiological procedure on an asymptomatic individual, performed for the early detection of disease—

    • (a) the procedure -

      • (i) is part of a health screening programme, or

      • (ii) requires specific documented justification for that individual by the practitioner, in consultation with the referrer, in accordance with guidelines published by the Authority in accordance with paragraph (6), and

    • (b) special attention is given to the provision of information to the individual, as required by paragraph (13).”.

GIVEN under my Official Seal,

25 June, 2025.

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 amend the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018.

This amendment makes more explicit the requirement to comply with guidelines published by the Health Information and Quality Authority when making a documented justification for a medical radiological procedure on an asymptomatic individual, performed for the early detection of disease, and with being in accord with guidelines.

These Regulations may be cited as the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) (Amendment) (No. 2) Regulations 2025.

Footnotes

1

OJ No. L 13, 17.1.2014, p. 1.

2

OJ No. L 72, 17.3.2016, p. 69.

3

OJ No. L 152, 11.6.2019, p. 128.

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