MEDDEV equivalent requirement to CFR 806.20

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Chuck in QA

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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Guillaume Prom

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"
 

somashekar

Leader
Admin
This attachment can help you Chuck in QA. Welcome to the COVE again
 

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