Transparency / Reciprocity - Medical device incident reported in the EU

P

pschnoor9

#1
Facts:

Medical device incident reported in the EU
  • incident did not meet the criteria for reportability (Death/serious injury/etc)
  • Device is built by US company and distributed in the EU
Question:

Does the manufacturer need to file an MDR with the FDA if the device was reported in the EU?
  • (there are no incidents associated with this device in the U.S., now or in the lifetime of the device)
  • I have searched 21 CFR 803, and there is no mention of this scenario - only from the aspect of foreign distributor to U.S.
  • Again - the incident does not meet the criteria for reportability, but was reported in the EU by another entity.
  • Our notified body was made aware by us that there was an event reported, but it did not meet the reporting requirements in the EU either.
Any advice/experience/opinion is welcomed and considered.

patricia
 
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Sidney Vianna

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#2
Re: Transparency / reciprocity

Facts:



Medical device incident reported in the EU
  • incident did not meet the criteria for reportability (Death/serious injury/etc)
Question:


Does the manufacturer need to file an MDR with the FDA if the device was reported in the EU?
Any advice/experience/opinion is welcomed and considered.

patricia
The FDA (@ http://www.fda.gov/ora/inspect_ref/fmd/fmd119.htm) states:
COMPLAINT DEFINITION
A consumer complaint is notification that a product in commercial distribution:
1. May be in violation of the laws or regulations administered by the FDA.
2. May have caused an illness, injury, or death.
3. Is alleged to have caused problems not covered by the above.
And according to Complaint Handling System - 21 CFR 820.198
Under the QS/GMP there continues to be no requirement that all complaints be maintained in one file. However, firms are now required to have written procedures for processing complaints.
 
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