Appropriate UK enforcing authorities
To submit a notification, the appropriate IR(ME)R enforcing authorities are:
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:
It is good practice for employers to report this type of incident (even if they have not resulted in a SAUE). This enables the UK Competent Authority for the Medicines and Medical Device Regulations (MHRA) to take appropriate action with the manufacturer.
Public or occupational exposures
Where a member of the public or a worker receives an over-exposure to ionising radiation, this needs to be reported to the Health and Safety Executive under Regulation 26 of The Ionising Radiation Regulations 2017.
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.
Health and Safety Executive Northern Ireland