Medical Devices Vigilance Procedure Example needed

jalocas

Registered
Hello to everyone.

As previously, I´m requesting some help. Does anyone have a template of a medical devices vigilance procedure for medical devices with CE marketing?

Which are the main diferences from a Pharmacovigilance procedure?

Best regards,
Jalocas
:thanks:
 
R

Roland Cooke

Re: Medical devices vigilance procedure

Hi, the new Rev 5 version of 2.12-1 is now available on the Meddev website. There are some changes, so its worth a read.


MEDDEV guidance isn't really guidance.:cool:

The requirements of the revised 2.12 must be implemented.
 
E

eddybauwens

:truce: Does anyone have an example of how vigilance is concrete organized within a company (procedures) ?
Thx
 
J

jdy11

We are a US manufacturer and our product is CE marked. Is it correct that if the product malfunctions with a serious injury and it happens in the US we only have to report to the FDA and not to anyone in Europe? There was no corrective action as a result of the incident.
 
E

eddybauwens

I don't think you should report to Europe.

MEDDEV 2.12-1 rev 5 (april 2007) mentions :

'INCIDENTs which occurred outside the EEA and Switzerland and 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 and Switzerland and led to a FIELD SAFETY CORRECTIVE ACTION relevant to the above-mentioned geographical areas must be reported as a FIELD SAFETY CORRECTIVE ACTION.'

:cool:
 
J

jdy11

Thank you for your reply! This is what I thought when I recently read the revision, however our ISO auditor has looked at our procedure that was written a couple of years ago and did not mention this. Our procedure reads that I must report these types of incidents to our Notified Body and our Authorized Rep. I am definately going to change it!
 
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