IR(ME)R annual report 2024/25

The Ionising Radiation (Medical Exposure) Regulations 2017 provide a legislative framework to protect patients against the hazards associated with ionising radiation.

The regulations state that each individual exposure should be justified and optimised to make it as effective as possible, and to ensure that the benefit for the patient outweighs the risk.

In the rare event when there is a significant accidental or unintended exposure to ionising radiation, the legislation requires that the IR(ME)R employer investigates the incident and notifies CQC under Regulation 8(4). Detailed criteria are available to IR(ME)R employers to explain when an incident needs to be notified to us.

As the relevant enforcing authority of IR(ME)R in England, we are responsible for monitoring compliance with IR(ME)R in England. We monitor compliance with the regulations through on-site inspections and by reviewing statutory notifications from healthcare services about significant accidental or unintended exposures to patients. The scope of our annual review of accidental and unintended exposures is to identify themes and consider learning opportunities. We do not include an assessment of clinical outcomes for patients.

The notifications we receive are a mix of accidental and unintended exposures:

• accidental exposures occur when a person receives an exposure in error, when no exposure of any kind was intended
• unintended exposures occur when a person is referred for a planned exposure, but the exposure delivered is significantly different to what was intended.

We also receive several voluntary notifications. These incidents do not meet the defined criteria or reporting threshold, but we share them for learning so that similar events can be mitigated.

This annual report

Under IR(ME)R Regulation 9, CQC is required to share relevant information regarding significant incidents, which we deliver in our annual IR(ME)R report.

During this reporting period (2024/25), amendments to the legislation were published and came into force on 1 October 2024. We granted a period of grace to all IR(ME)R employers allow time to incorporate the required changes to their procedures and processes before we started to inspect against the amended regulations on 1 April 2025. This means that in this year’s report, we do not include an analysis of our findings against the amendments.

We report on what we have found from our annual inspection programme through an overview of compliance with the regulations. This enables other employers, healthcare professionals and academic bodies to learn from the examples of errors and good practice.

We provide a summary of our total IR(ME)R regulatory activity for 2024/25, and under each of the 3 modalities, the report further provides:

• a summary and analysis of the statutory notification data
• our inspection and enforcement actions in that area
• details of some of the most prevalent themes identified during the year, with some recommendations for IR(ME)R employers to consider.