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SAUE: Appropriate enforcement authorities
We updated our guidance on significant accidental or unintended exposures (SAUE) on 24 August 2020.
To submit a notification, the appropriate IR(ME)R enforcement authorities are:
England: The Care Quality Commission
Wales: Healthcare Inspectorate Wales
Northern Ireland: The Regulation and Quality Improvement Authority
Scotland: Healthcare Improvement Scotland
Reporting device-related incidents
Where there are risks to individuals relating to medical devices, employers should consider reporting all device and medicine-related incidents to other agencies including:
England and Wales: Medicines and Healthcare Products Regulatory Agency (MHRA)
Scotland: Health Facilities Scotland
Northern Ireland: The Northern Ireland Adverse Incident Centre
It is good practice for employers to report such incidents (even if they have not resulted in SAUE), as this enables the UK Competent Authority for the Medicines and Medical Device Regulations (MHRA) to take appropriate actions with the manufacturer.
Public or occupational exposures
Where members of the public or workers receive over-exposures to ionising radiation, these need to be reported to the Health and Safety Executive under Regulation 26 of The Ionising Radiation Regulations 2017.
England, Scotland and Wales: Health and Safety Executive
Northern Ireland: Health and Safety Executive Northern Ireland
Over-exposures resulting from equipment faults before the equipment is put into clinical use, for example, for critical examination, should also be reported to the Health and Safety Executive.
- Last updated:
- 21 August 2020