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 (https://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, (broken link removed)). 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
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 (https://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, (broken link removed)). 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