There is a lot going on here. First, it would be useful to know which Notified Body and how they advised. A nonconformance report issued during an audit may not represent a policy.
The post seems to confuse two things. In the one case a vigilance report represents an adverse event reported to regulators. In the other case, Field Safety Corrective Actions and Field Safety Notices represent a recall. Only a small number of vigilance reports result in a recall.
It would seem reasonable that a manufacturer would evaluate each received complaint for vigilance reporting. The requirement for FSCA & FSN is a different question.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 07-21-2014 13:07
From: Gary Syring
Subject: Vigilance Reporting
A Notified Body has advised that every complaint received for a CE Marked product, whether the complaint is received from the European Economic Area (EEA) or outside the EEA, requires justification for no vigilance report support, similar to the justification for no FDA Medical Device Report. Justification that no adverse event occurred in the EAA and no field safety corrective action will be issued is not acceptable.
This interpretation seems to be inconsistent with MEDDEV 2 12-1 rev. 8 Vigilance states: INCIDENTs which occurred outside the EEA, Switzerland and Turkey do not lead to a FIELD SAFETY CORRECTIVE ACTION relevant to these geographic areas do not need to be reported. Incidents which occurred outside the EEA, Switzerland and Turkey led to a FIELD SAFETY CORRECTIVE ACTION relevant to the above-mentioned geographical areas must be reported as a FIELD SAFETY CORRECTIVE ACTION.
Has anyone had similar experience with a Notified Body stating any complaints received for a CE Marked product require justification for vigilance reporting beyond the reported event did not occur in the EEA and the reported event did not lead to a field safety corrective action?
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Gary Syring RAC
Prin Consultant
Quality & Regulatory Associates LLC
Stoughton WI
United States
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