MEDDEV equivalent requirement to CFR 806.20

C

Chuck in QA

#1
#1
I'm interested in researching the equivalent aspect of the Medical Device Directive that coincides with the CFR 806.20 corrections and removals not required to be reported. In the case of MEDDEV I guess what I'm looking for is not to file a vigilance report when correction and removal for EU devices.
 
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G

Guillaume Prom

#2
#2
No MEDDEV for this point, but you could take a look at:
- NBOG’s Best Practice Guide "Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System"
- NB-MED/2.5.2/Rec2 "Reporting of design changes and changes of the quality
system"
 
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