Is vigilance the responsibility of all

Global distributor vigilance responsibility

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
Thank you so much dear
The point that the manufactur doesnt agree to sign vigillance commitment based on his agreement with the distributer??
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.
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 was only seeking if any regulations could support the above mentioned claim ,sorry for inconvenience
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.
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
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.

Attachments

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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