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Global distributor vigilance responsibility

#1
Hi all,
Will you enlighten me with the exact REGULATIONS that a medical device GLOBAL distributor which enter quality agreement with manufacturer so he will be by turn undertakes all vigilance responsibility and deal with different competent authorities .
Thank you very much guys! :thanks
 
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indubioush

Quite Involved in Discussions
#2
I assume you are talking about vigilance reporting in Europe. I also assume the device is not an in vitro diagnostic. If this is the case, you will want to refer to the European medical device regulation. Do a search for "vigilance" and you will find the specific section with that title.

Also read the guidance on vigilance: DocsRoom - European Commission

Please know that the medical device manufacturer is ultimately responsible for post-market surveillance, so you should be looking to them for instruction and guidance.

Also see the competent authority contact list: Contacts - Internal Market, Industry, Entrepreneurship and SMEs - European Commission
 
#3
Thank you so much dear
The point that the manufactur doesnt agree to sign vigillance commitment based on his agreement with the distributer??
 
#5
I just want to ensure legal manufacturer reponsabilities in front of a cimpetent authority in case that the distributer by turn had to undertakes these responsability upon former quality agreement with the legal company.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
I just want to ensure legal manufacturer reponsabilities in front of a cimpetent authority in case that the distributer by turn had to undertakes these responsability upon former quality agreement with the legal company.
I am no expert on this matter, but it is clearly a highly complex subject ,with profound legal and liability implications. Obviously, you should be seeking expert legal counseling on this and not expect legal advice for free on a discussion blog.
 
#7
I am no expert on this matter, but it is clearly a highly complex subject ,with profound legal and liability implications. Obviously, you should be seeking expert legal counseling on this and not expect legal advice for free on a discussion blog.
i was only seeking if any regulations could support the above mentioned claim ,sorry for inconvenience
 

Mikilk

Involved In Discussions
#8
I just want to ensure legal manufacturer reponsabilities in front of a cimpetent authority in case that the distributer by turn had to undertakes these responsability upon former quality agreement with the legal company.
If you are referring to the EU law it is all under the new medical device regulations, see article 14 of the MDR, you can also use the BSI guidance attached
 

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Watchcat

Trusted Information Resource
#9
Will you enlighten me with the exact REGULATIONS
not expect legal advice for free
i was only seeking if any regulations could support
I am very sympathetic to SV's general perspective on this, because we get a lot of that around here, and not just limited to free legal advice, but for free consulting services on a variety of complex topics. In this case, however, I am inclined to think the request was well within the bounds of an appropriate query for an online forum, as it was not for advice or how-to instructions, but just for a reference to "the exact REGULATIONS."

I hope Mikilk was able to provide you with what you needed to assure (not ensure, personal pet peeve) what you needed to assure.
 
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