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SAUE: Appropriate enforcement authorities

  • Organisations we regulate

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