Validity of NB-MEDs (MDD / CE marking)

Peter Selvey

Leader
Super Moderator
#1
Dear forum,

In doing research for a client, and I am again wondering about the validity of NB-MEDs in European MDD CE marking.

Naturally, no "guides" are law, however modern regulations usually have high level guides which are treated as defacto-law, such as the MEDDEVs in Europe.

Many of the Notified Bodys (NBs) give NB-MEDs a similar status - i.e. not law but mandatory in practice.

However, while MEDDEVs are clearly endorsed by the European Commision, NB-MEDs seem to be missing any government level endorsement.

The "Team-NB" website (http://www.team-nb.org/), appears to be the official site housing the NB-MEDs, but this is not linked or referenced in the official Europa website. This Team-NB site also seems to be not updated, and finding a specific NB-MED document is not easy.

Further, there is a new organization NBOG (Notified Bodies Operation Group, http://www.nbog.eu/index.html). This site is created by the European commision, i.e. includes government representation, and has a specific task of reviewing and endorsing guidance documents, including those provided by NB-MED. A 2008 report refers to a long list of NB-MEDs that remain to reviewed, after which they may be converted to MEDDEVs.

With this in mind, it would appear that existing NB-MEDs should not be treated as defacto-law, at least until such time as they are endorsed by the EU commision.

I would be interested in anyone who has information on the status of these NB-MEDs, which may include people inside the NBs who may have better understanding of the current situation.

Thanks,

Peter
 
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SteveK

#2
Hi Peter,

I'm glad you raised this (links to your response to my previous post). I have contacted my NB about this very point as they use a form for (electronic) Techical File submissions/amendments based on the NB-MED clause structure. I will post what feedback I get.

Steve
 
S

SteveK

#3
As indicated - feedback from our NB.

Quote: The Technical File Review document (based on the NB-MED clauses - my insert) is the one we use for our review of technical files. Bearing in mind, the document is not a mandatory requirement, we will review the information you submit (in whatever format).

So there you go!

Steve
 
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