EU Vigilance (updated MEDDEV rev.5) - Internal Forms

B

Bassman84

#11
Re: EU Vigilance - Internal Forms

Is it reasonable to report to the NCAs of various middle eastern countries on the MEDDEV vigilance reporting form? Or should I generate a seperate document based on GHTF universal data set?
 
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sreenu927

Quite Involved in Discussions
#12
1. You need to follow the format of your Company procedure to be in compliant with your Quality management System.

2. If you don't have - then you can look into that particular Country's regulatory authority website for any prescribed format.

3. If not, then come out with a procedure to include the format of the reporting forms, in line with MEDDEV Guidance docs, provided if you are satisfied with that or else modify to your company needs and then use that format to report the incidents.

Hope this helps!

Regards,
Sreenu
 
B

Bassman84

#13
Hi Sreenu,

Thanks for the input. I guess I am left with option 3 as I am making the vigilance procedure for MIE countries.

Ill use the GHTF universal dataset while making a document I can use for such reporting. I find it odd that there isnt a prescribed document for this - perhaps its because the ghtf countries are not yet harmonised on the layout of the document-reporting-front

Thanks again,
 
#14
Any tips on what are key sections of an adverse incident form for reporting to NB?

Stuck here. Trying to generate one using meddev example- are there any other websites which suggest how to do this or provide templates?

:thanx:
 
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