Change in Lot Release Specifications - Definition of "Substantial Change"

Chrisx

Involved In Discussions
#11
I used to work for TUV SUD. I was told their contract with their designating authority (ZLG) requires they follow NBOG guidances. It is probably the same for all German notified bodies. This particular one was sent to me from our BSI scheme manager and they seem to apply NBOG guidances. Not sure about all the other notified bodies. I think that in general NBOG guidances hold more weight as they are enforced by the designating authority. Team-NB is a voluntary professional organization with no enforcement authority.
 
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maxximase

#12
I used to work for TUV SUD. I was told their contract with their designating authority (ZLG) requires they follow NBOG guidances.
Thanks for the response. I reached out to a BSI scheme manager I know who also said they advise to follow the NBOG documents.

Separately, I have a colleague using DQS as their NB -- they have been told to follow EK-MED documents -- these appear to be NBOG documents with a German cover page. :confused:
 

Chrisx

Involved In Discussions
#13
To be more precise the contract for TUV SUD requires compliance to EK-Med guidances. The head of their designating authority (Dr. Edelhauser) is also the chair of NBOG. So, he made the NBOGs into EK-Meds, so that the contract would require compliance to both. Not all EK-Meds are NBOGs. There are additional EK-Med guidances at https://www.zlg.de/medizinprodukte/dokumente/antworten-und-beschluesse-ek-med.html

Most are only in German, a few have been translated into English.
 
M

maxximase

#14
To be more precise the contract for TUV SUD requires compliance to EK-Med guidances. The head of their designating authority (Dr. Edelhauser) is also the chair of NBOG. So, he made the NBOGs into EK-Meds, so that the contract would require compliance to both. Not all EK-Meds are NBOGs. There are additional EK-Med guidances at "link"

Most are only in German, a few have been translated into English.
So when I use google to translate that link, I see the following message:
Since April 2009, also by the Notified Body Operations Group (be NBOG ) developed "best practice" documents - substantially unchanged - in the range of EK-Med received decisions. These documents are not translated into German. Already published EK-Med documents on the same subject can only be withdrawn if it was granted contrary to European NBOG should be document.
Does this mean that if a US based company is using a German notified body, that they are first required to comply with the EK-Med documents and, if no such document exists for a particular topic, then the corresponding NBOG document would apply?

There is apparently some hierarchy here that I am trying to make sense of between the NBOG, NB-MED and EK-Med documents.
 

Chrisx

Involved In Discussions
#15
I wouldn't lose too much sleep over it. The important ones have been translated or replaced by NBOG guidances. Many of the ones in German don't add much value. As I recall one just states how to find the list of harmonized standards. The EK-Med on declaration of conformity is in English. Explaining to clients why they had to comply to obscure German guidance documents was always great fun. :( The one on OEMs used to be available in English. I think they updated it, but didn't translate the update. It is a struggle both for American companies and American auditors working for TUV.
 
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