Report an Incident to the Anser Medical and the Device Manufacturer


The UK medical device competent authority is the Medicines and Healthcare products Regulatory Agency (MHRA) and on their website they define the criteria for incidents to be reported to them as follows: 

         "Any event which meets all three reporting criteria below is considered an adverse incident and must be reported to the MHRA:
  • an event has occurred. This includes situations where testing performed on the device, examination of the information supplied with the device, or any scientific information indicates some factor that could lead, or has led, to an event
  • the manufacturer’s device is suspected to be a contributory cause of the incident 
  • the event resulted in, or might have resulted, in death or a serious deterioration in state of health of a patient, user or other person
Not all adverse incidents result in death or a serious deterioration in health. These may have been prevented because of other circumstances, or because of intervention. Therefore, you must still send us a report if:
  • an incident associated with a device happened, AND
  • if it occurred again, it might lead to death or serious deterioration in health
Adverse incidents involving medical devices that occur in the UK must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA). "

As part of on going market surveillance by manufacturers of their medical devices it is very important that end users report incidents without delay so rapid corrective action can be implemented. 

By completing the below Incident Report Form helps our organisation as the UK Responsible Person for the international device manufacturers we work with to take the neccessary corrective action in conjuction with the MHRA.

Note: this Medical Device Incident Report Form will be sent to Anser Medical who will forward the document to the specific manufacturer of the relavent device.

Medical Device Incident Report Form

Share by: