Bottom-up Medical device vigilance involves reporting a defect on an equipment template having caused incidents to the ANSM (National Agency for the Safety of Medicines and Health Products).
This function guides you in entering and tracking the information that will be used to produce the form to be sent to the ANSM.

Creating bottom-up biomedical device recall

1. In the [Work] module, select the [Ascendant biomedical device recall] function,
   → The list of ascendant medical device vigilance reports is displayed.
   
   
2. Click on the add icon .
   → The create an ascendant biomedical device recall form is displayed.

Sending bottom-up biomedical device recall

1. Once the information has been filled in and the form is ready to send, fill in the "Transmittal date" field
   → It is then possible to close the biomedical device recall.
   
   
2. On the status menu , select "Close request."
   → The form to be sent to the ANSM is displayed, then the request changes to the "Closed" status.