Ionising Radiation (Medical Exposure) Regulations 2017
What this means for your business
- Enforced by
- MHRA
- Applies to
- United Kingdom
- On this page
- 12 compliance obligations, 1 practical guide
What you must do
12 compliance obligations under this legislation.
Appointments 1
Appoint and involve a qualified medical physics expert
If your business provides medical exposure to ionising radiation, you must appoint a suitably qualified medical physics expert and ensure they are involved in the planning, optimisation, quality assurance and safety of all relevant radiological practices. Their advice must be used for dosimetry, equipment testing, training staff and responding to any accidental exposures.
Management duties 8
Establish and maintain radiation procedures, protocols and QA programmes
Unlimited fineIf your business uses ionising radiation for medical purposes, you must have written procedures and protocols covering all required matters and make sure staff follow them. You also need to provide ongoing training, set up quality‑assurance and dose‑reference level programmes, regularly review reference levels and take corrective action when they are exceeded, and keep records of dose surveys and information for referrers and patients.
Include clinical audit in radiation safety procedures
If your business uses ionising radiation for medical purposes, you must have written procedures that set out how you will carry out regular clinical audits of those exposures. You also need to act on any findings from the audit to improve safety and quality.
Justify and authorise every medical radiation exposure
Before you carry out any procedure that uses ionising radiation on a patient, you must be sure it is licensed, clearly beneficial, formally authorised and, where required, approved by ethics or expert committees. You also need to follow your own safety procedures and check pregnancy or breastfeeding status for people of child‑bearing potential.
Justify and manage medical radiation exposures in line with procedures
If your business provides medical imaging or radiotherapy, you must follow your employer’s radiation safety procedures, make sure every exposure is clinically justified, and get the necessary medical information from the referrer before the procedure. You also need to keep records of authorisations and work together with other specialists involved in the exposure.
Keep radiation doses as low as reasonably practicable
If you run a service that uses ionising radiation for medical diagnosis or therapy, you must make sure every exposure is planned and carried out so that the radiation dose is as low as is reasonably possible while still achieving the clinical purpose. This means having written procedures, quality‑control checks, dose‑assessment tools and patient information in place and checking they are followed each time a patient is scanned or treated.
Manage accidental or unintended radiation exposures
If a patient or staff member receives a clinically significant unintended or accidental radiation dose, you must have procedures to tell the referrer, practitioner and the person affected (or their representative). You also need to study the risk of such events, keep records of any analysis, investigate any suspected over‑ or under‑exposure straight away, notify the regulator and report the outcome and any corrective actions taken.
Manage and maintain safe radiological equipment
If your business controls any equipment that emits ionising radiation, you must put in place a quality‑assurance system, keep a detailed inventory, test the equipment before first use and at regular intervals, and take action to fix any performance problems. This means you need to plan, monitor and record how the equipment is used, maintained and kept fit for purpose.
Share radiation exposure information with other employers
If more than one employer is involved in providing a medical ionising‑radiation procedure for the same person, you must cooperate by exchanging the relevant exposure details. This ensures every employer can meet the legal requirements for that individual's radiation safety.
Registration and licensing 1
Hold a valid licence for any radiological work
If your business employs staff who use radioactive substances or you personally administer them for diagnosis, treatment or research, you must have a licence from the Licensing Authority. The licence must cover each installation and each purpose before any radioactive substance is used and must be kept up to date.
Reporting and filing 1
Collect and report population dose estimates
If your business uses ionising radiation for medical purposes, you must keep records of the radiation doses patients receive, broken down by age and gender. When the Secretary of State asks for these figures you must supply them. This is a routine part of your radiation safety monitoring.
Training 1
Ensure staff are trained and keep training records for radiation work
You must make sure any practitioner or operator who carries out a medical ionising radiation exposure has completed adequate training before doing the work. You also have to keep an up‑to‑date record of each person's training dates and details, and have it ready for inspection or to give to a partner employer if asked.
Penalties for non-compliance
1 penalty under this legislation. 1 carry an unlimited fine.
Establish and maintain radiation procedures, protocols and QA programmes
Unlimited fine
Practical guidance
Our guides explain how to comply with the requirements above.
Sections and provisions
23 classified provisions from this legislation.
Duties 13
- s.5 Requirement to hold a licence
- s.6 Employer’s duties: establishment of general procedures, protocols and quality assurance programmes other matter in relation
- s.7 Employer’s duties: clinical audit appropriate action in relation
- s.8 Employer’s duties: accidental or unintended exposure appropriate action in relation
- s.9 Relevant enforcing authority’s duties: accidental or unintended exposure
- s.10 Duties of the practitioner, operator and referrer
- s.11 Justification of individual exposures A person
- s.12 Optimisation
- s.13 Estimates of population doses
- s.14 Expert advice type of exposure
- s.15 Equipment: general duties of the employer A person
- s.17 Training
- Employer’s duties: co-operation between employers Employer’s duties: co-operation between employers other