Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

For EU vigilance, my company has interpreted the source of an incident as an event coming from product that has been distributed commercially.  Recently I heard a different interpretation of this from another company.  If they find a nonconformance internally on a lot that has been distributed in the field which meets all the criteria for an incident, they will file a vigilance report, even if they have had no events related to the nonconformance from the field.
I can see where they get their interpretation.  I'd like to hear other companies' perspectives on this.  

​Hello,

From the information you provided below, it looks like you are saying similar things.  Both products have been made available on the Union market, therefore, they are in commerical distribution. 

For a product that an incident has occured (I am assuming this is a malfunction or adverse event of some sort), you would follow the process of the EU Incident Report.  When you find a nonconfomrity on your product from an internal perspective, and you have product from that lot made available in the market, you need to work with your team to determine if a market action is needed, since there has not been an incident (adverse event) that has occur.  This would be a Field Safety Corrective Action (recall/market withrdrawal) and you would need to fill out the applicable reports for this. 

Both scenarios you mentioned are vigilance activities, however, the process for each is slightly different.  I hope this helps!


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Adam Cargill RAC
Regulatory Affairs Manager
Warsaw IN
United States
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Original Message:
Sent: 20-Jun-2018 09:38
From: Anonymous Member
Subject: Interpretation of Meddev 2.12-1 "Incident" for EU Vigilance

This message was posted by a user wishing to remain anonymous

For EU vigilance, my company has interpreted the source of an incident as an event coming from product that has been distributed commercially.  Recently I heard a different interpretation of this from another company.  If they find a nonconformance internally on a lot that has been distributed in the field which meets all the criteria for an incident, they will file a vigilance report, even if they have had no events related to the nonconformance from the field.
I can see where they get their interpretation.  I'd like to hear other companies' perspectives on this.

The Meddev states, "Any event which meets all three basic reporting criteria A – C listed below is considered as an INCIDENT and must be reported to the relevant National Competent Authority. The criteria are that: 

A: An event has occurred  

This also 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.

I've never liked this part of the MedDev because it switches between event and incident.

For example, 5.1.1 says, "Any event which meets all three basic reporting criteria A – C listed below is considered as an INCIDENT" and is reportable. In part B the language switches from event to incident, which is, in my opinion, an error.

That said, I think the question is whether an event, from Part A, requires an external report, such as from a patient or user. The way Part A is written, an event can occur based on either internal information or external information.

As an example, looking at section g), if the label provided an incorrect expiration date (too long so the product could have deteriorated) that would be an event. If the label had the wrong street address (reversing the digits of the building number) that would also be an event. Both of them could have occurred in an internal review such as an audit finding.

However, not all events are incidents because an incident must meet all three criteria. (For Part B, read event for incident.)

In both examples, Part A and Part B are satisfied. The incorrect expiration date would satisfy Part C, making it an incident and reportable. The incorrect address would not satisfy Part C, so it is not an incident.

To pursue the next potential question, the incorrect expiration date should also generate a Field Safety Corrective Action while the incorrect address would not.

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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 20-Jun-2018 09:38
From: Anonymous Member
Subject: Interpretation of Meddev 2.12-1 "Incident" for EU Vigilance

This message was posted by a user wishing to remain anonymous

For EU vigilance, my company has interpreted the source of an incident as an event coming from product that has been distributed commercially.  Recently I heard a different interpretation of this from another company.  If they find a nonconformance internally on a lot that has been distributed in the field which meets all the criteria for an incident, they will file a vigilance report, even if they have had no events related to the nonconformance from the field.
I can see where they get their interpretation.  I'd like to hear other companies' perspectives on this.

The Meddev states, "Any event which meets all three basic reporting criteria A – C listed below is considered as an INCIDENT and must be reported to the relevant National Competent Authority. The criteria are that: 

A: An event has occurred  

This also 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.