The European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 (and associated amendments) provide a framework for regulating medical exposure to ionising radiation in Ireland. HIQA is the competent authority in Ireland with a number of responsibilities with respect to the justification of practices. 

  • HIQA must justify:
    • any new practices that involve exposing patients to ionising radiation before they are generally adopted*
    • existing practices that involve exposing patients to ionising radiation, if new and significant information becomes available about the efficacy or safety of the practice itself or about any alternative practice that could replace it
    • medical radiological procedures to be performed as part of a health screening programme prior to the commencement of the screening programme.

* ’generally adopted’ means the practice is used for broad categories of patients, rather than individual patients. The process whereby HIQA approves a practice for a broad category of patients is also known as ‘generic justification’.

  • HIQA must publish guidelines on the specific justification of medical radiological procedures on asymptomatic individuals, performed for the early detection of disease but not as part of a health screening programme.

To apply for the generic justification please see information below

HIQA has commenced its generic justification function. This means that hospitals and service providers in the public and private sectors who wish to provide a new type or class of practice involving ionising radiation in Ireland must apply to HIQA for generic justification before they can use the practice on a routine basis.

To apply for the generic justification of a new type or class of practice which involves a medical exposure to ionising radiation please click to see the application form and a methods document, which outlines how HIQA will carry out generic justification.

If you have any queries about generic justification, please email radiationjustification@hiqa.ie or phone (021) 240 9300.

See information on HIQA's EAG which advises on its medical exposure to ionising radiation functions

HIQA has an Expert Advisory Group (EAG) to advise on its medical exposure to ionising radiation functions. This standing EAG includes patient and public representation as well as representatives from regulators and key professional bodies. The EAG is responsible for reviewing the available evidence about practices and making a recommendation to HIQA about whether the practices should be generically justified. Please click here to see the current members of the Expert Advisory Group and terms of reference for this group.

The dates for the EAG meetings in 2025 are: 

  • Thursday, 27 February at 2pm
  • Thursday, 26 June at 2pm
  • Thursday, 23 October at 2pm

See list of applications for generic justification currently in progress:

Published reports on the justification of practices involving medical exposure to ionising radiation

Following consideration of the evidence and the recommendation of its Medical Exposure to Ionising Radiation Expert Advisory Group, HIQA has issued decisions with respect to the following types and classes of practice:

PracticeDecisionDate EffectiveUnderpinning evidence
¹⁷⁷Lu oxodotreotide for the treatment of metastatic or inoperable gastroenteropancreatic neuroendocrine tumours (GEP-NETs)Generically justified20 April 2023Report
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A slot-scanning, biplanar, digital X-ray imaging system for the evaluation and monitoring of orthopaedic conditionsGenerically justified10 July 2023Report
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Ultra-hypofractionated adjuvant radiotherapy for breast cancerGenerically justified 16 November 2023Report
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¹⁸F-prostate-specific membrane antigen (PSMA) PET/CT imaging for the staging of high-risk or recurrent prostate cancerGenerically justified 15 December 2023Report
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¹⁷⁷Lutetium PSMA radioligand therapy for the treatment of metastatic castrate-resistant prostate cancerGenerically justified 18 April 2024Report
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Magnetic resonance-guided radiotherapy (MRgRT) for patients with cancer requiring external beam radiotherapyGenerically justified16 June 2025Report
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See below details of information events held by HIQA

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You can download the presentation slides which accompany this webinar.

  • Generic Justification Application Form

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  • Methods for Generic Justification

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