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Mandatory Steps for Assessing Incidents
Mandatory Steps for Assessing Incidents
Collect as much information as possible concerning the case
Collect as much information as possible concerning the case
What happened? Is a device involved in the incident?
Which device? Which lot/batch/expiry date?
How was the device used? By whom?
What were the consequences of the incident?
Is the device available for analysis?
What happened? Is a device involved in the incident?
Which device? Which lot/batch/expiry date?
How was the device used? By whom?
What were the consequences of the incident?
Is the device available for analysis?
Inform your EAR (European Authorized Representative) and provide the gathered information
Inform your EAR (European Authorized Representative) and provide the gathered information
Assess together with your EAR the reportability of the case
Assess together with your EAR the reportability of the case
If reportable, an Initial Incident Report needs to be prepared and submitted in due time to the relevant Competent Authorities
If reportable, an Initial Incident Report needs to be prepared and submitted in due time to the relevant Competent Authorities
Due to the medical nature of the devices, incidents are bound to happen sooner or later
It is therefore crucial for any manufacturer to know how to react!
Due to the medical nature of the devices, incidents are bound to happen sooner or later
It is therefore crucial for any manufacturer to know how to react!
Did you know?
It is a legal obligation to report incidents to the Competent Authorities and to maintain a Medical Devices Post Market Surveillance System!
Did you know?
It is a legal obligation to report incidents to the Competent Authorities and to maintain a Medical Devices Post Market Surveillance System!
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Facing an incident case and unsure about its reportability?
Facing an incident case and unsure about its reportability?
What to do when an incident occurs?
What to do when an incident occurs?
Medical Devices Vigilance
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Medical Devices Vigilance
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We are introducing the new Vigilance Card program, providing you with everything you need in otder to deal with medical devices' incidents.
We are introducing the new Vigilance Card program, providing you with everything you need in otder to deal with medical devices' incidents.