One of our clients is using a device he purchased to us to perform a clinical trial outside our CE mark indications. He is the sponsor and the investigator, we are not involved in his activity at all.
However he has reported us an adverse event (no SAE). This event is not related to the indication under trial (it already occured with the cleared indications and is part of our risk analysis) but rather to the (abnormal) use of the device.
Do we have to treat the event as part of our NC and vigilance processes ?
Thank you for your help,
Vivien
However he has reported us an adverse event (no SAE). This event is not related to the indication under trial (it already occured with the cleared indications and is part of our risk analysis) but rather to the (abnormal) use of the device.
Do we have to treat the event as part of our NC and vigilance processes ?
Thank you for your help,
Vivien