Ionising Radiation (Medical Exposure) Regulations 2017

Regulations

IR(ME)R 2017 and IR(ME)R (NI) 2018 including 2024 Amendments

The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2024 come into effect on 1st October 2024 in England and Wales and Scotland.

The Ionising Radiation (Medical Exposure) Regulations IR(ME)R 2017 (2018 in Northern ireland) came into effect on 6th February 2018 and replaced The Ionising Radiation (Medical Exposure) Regulations 2000, (IR(ME)R 2000). 

For the purposes of our website, when we use IR(ME)R, we mean:

• The Ionising Radiation (Medical Exposure) Regulations 2017 
• The Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018
• The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2018
• The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2024

The Regulations implement, in Great Britain, some of the provisions of Council Directive 2013/59/Euratom which lays down basic safety standards for protection against the dangers from exposure to ionising radiation.

The Regulations are available from The Stationery Office here.

IR(ME)R supports the safe delivery of medical exposures, enabling a variety of practices to be undertaken safely within a robust governance framework. 

Responsibility for compliance with IR(ME)R rests with the employer and all entitled duty holders as defined in the Regulations.

IR(ME)R is legislation aimed at the protection of the patient against the hazards associated with ionising radiation. It is made as criminal law rather than civil law. The main difference being that if there is a breach of civil law then the law seeks to establish fault and award compensation; in criminal law an illegal act is punished, compensation is a secondary issue.

The enforcing authorities for IR(ME)R are:

England The Care Quality Commission (CQC)

Find out how to make a notification to CQC. 

The CQC produces an annual report in line with the requirement of regulation 9. It provides a comprehensive summary of notifications, recommendations for employers and lessons learned from significant events.

CQC IR(ME)R inspections of specialist paediatric radiology services 2019

Notifications can be made directly to CQC by using their web-based notification form.

Northern Ireland Regulation and Quality Improvement Authority 

Incidents in Northern Ireland which have gone through a local preliminary investigation and which results in a patient receiving a radiation dose that is classed as significant accidental or unintended or clinically significant accidential or unintended must be reported to RQIA.

Notify RQIA of an accidental or unintended exposure incident here.

Scotland Healthcare Improvement Scotland 

The enforcing authority for Scotland for the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) is Healthcare Improvement Scotland.

Notify HIS of an accidental or unintended exposure incident here.
 

Wales Healthcare Inspectorate Wales

Employers must tell us about exposures judged to be ‘significant’ or ‘clinically significant’ accidental or unintended exposures.

Notify HIW of an accidental or unintended exposure incident here. 

By email: [email protected]

By post:
IR(ME)R Incidents,
Regulation Team
Healthcare Inspectorate Wales
Bevan House, Caerphilly Business Park
Van Road, Caerphilly
CF83 3ED
02920 92 8921

NHS Organisations are also required to inform the Welsh Government of IR(ME)R incidents as part of Serious Incident reporting procedures.

The annual report which includes compliance with the Ionising Radiation (Medical Exposure) Regulations (IRMER) in Wales is available from Healthcare Inspectorate Wales:

Ionising Radiation (Medical Exposure) Regulations IR(ME)R 2017 and for Northern Ireland IR(ME)R NI 2018

The Ionising Radiation (Medical Exposure) (Amendment) Regulations 2018

The Ionising Radiation (Medical Exposure) Regulations 2017: guidance

Guidance

As well as the requirements placed on us by law, professional standards of proficiency and codes of conduct should be considered in matters related to radiation protection. Further support and advice is available as professional body guidance and the Quality Standards for Imaging.  

• IR(ME)R: Implications for clinical practice in diagnostic imaging, interventional radiology and diagnostic nuclear medicine

• Ionising Radiation (Medical Exposure) Regulations: Implications for clinical practice in radiotherapy. Guidance from the Radiotherpay Board

• Breast screening: guidance on implementation of Ionising Radiation (Medical Exposure) Regulations (2017)

• Towards Safer Radiotherapy

• Inclusive pregnancy status guidelines for ionising radiation: Diagnostic and therapeutic exposures

• Clinical Imaging Requests from Non-Medically Qualified Professionals (3rd Edition)

• The Radiographic Assistant Practitioner’s role in Quality Control of Radiological Equipment

• Ionising Radiation (Medical Exposure) Regulations 2017; briefing for radiographers who undertake commenting or reporting

• Communicating Radiation Benefit and Risk Information to Individuals Under the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R)

• The impact of IR(ME)R 2017 IR(ME)R (NI) 2018 on pregnancy checking procedures

• The Diagnostic Radiographer as the entitled IR(ME)R Practitioner

• Student radiographers and trainee assistant practitioners: verifying patient identification and seeking consent

• Student radiographers & trainee assistant practitioners as “Operators” under IR(ME)R 2017 (2018 in Northern Ireland)

• Protection of Pregnant Patients during Diagnostic Medical Exposures to Ionising radiation: Advice from the Health Protection Agency, The Royal College of Radiologists and the College of Radiographers

• Protection of Pregnant Patients: Sample decision flow chart (to be read in conjunction with "Protection of Pregnant Patients during Diagnostic Medical Exposures to Ionising Radiation)

• The Quality Standard for Imaging | CoR (collegeofradiographers.ac.uk)

• Quality Standard for Imaging Networks (QSIN)

Useful notes

i) Employers Procedures
“Employers Procedures” (as required under Schedule 2 of the regulations) – within these Procedures there needs to be clarity around:

• Who undertakes the different roles identified (ie the referrer, the practitioner and the operator)
• The process for ensuring that individuals to be exposed are not pregnant
• Procedures to measure the actual dose given to the individual
• Procedures for the use of diagnostic reference levels (DRL’s)  - not expected to exceed published DRL’s for normal radio-diagnostic examinations

ii) Diagnostic Reference Levels
The Ionising Radiation (Medical Exposure) Regulations 2017 (IR(ME)R) require that employers establish and make available to an operator, Diagnostic Reference Levels (DRLs) and undertake appropriate reviews if they are consistently exceeded.

National DRLs can be found here.

Helpful patient dose information and typical effective doses, equivalent periods of natural background radiation and lifetime fatal cancer risks from diagnostic medical exposures is available from UK Health Security Agency.

iii) Guidance has been written by SoR, RCN, RCR and CSP to help those healthcare practitioners registered with a healthcare regulatory body who wish to take on the role of IR(ME)R 'Referrer' within clinical imaging departments. The guidance is available in the policy and guidance document library.

The guidance sets out a policy position on handling this type of request which was agreed by all the contributing organisations and includes legal and professional requirements under IR(ME)R. The IR(ME)R Referrer is required to have a knowledge of IR(ME)R and radiation exposure risks.

Following the publication of this guidance the College of Radiographers developed an IR(ME)R awareness training study day for Nurses and Allied Health Professionals. Similar training is generally available within local diagnostic imaging departments - A typical programme would include: IR(ME)R Referrer Programme.

iv) Examples of IR(ME)R training questions have been written by Maria Murray (Professional Officer for radiation protection) these may be used and modified as required to help radiographic staff gain a better understanding of the IR(ME)R regulations.

IR(ME)R training excercises

v) Guidance for implementing IR(ME)R in radiotherapy is available in the document library here.
This guide will be of benefit to chief executives, medical directors, human resources departments and all professionals involved in the delivery of radiotherapy. This document aims to address a series of frequently asked questions (FAQs) which have come up in formal inspections or have been brought to the attention of the Working Party by its members from their own departments and professions.

vi) Revised IR(ME)R Criteria for Significant Accidental and Unintended Exposures. As of June 3rd 2019, MGTI and PM77 were revoked and new criteria for statutory notifications under Regulation 8(4) were published. The IR(ME)R enforcement authority will no longer accept notifications following MGTI or PM77 so please ensure that SAUE criteria is followed. The new notification webform has been carefully constructed to intuitively follow the new criteria. The form and the associated guidance can be found here.