Notified Body excessive reporting onto Competent Authorities via the Eudamed database

N

Nissim Shaked

Shaked
Dear all,

If we suspect that a certain Notified Body is using lately the EUDAMED database
to show that it is a "good" NB.
Especially in the favor of the last recast to reduce the number of active NB
Is there any way to check such excessive use of a certain NB?
Thanks
Nissim
 
M

MIREGMGR

Re: Notified Body overflow use of Eudamed

Nissim or anyone else, please explain the context for the question being asked here.

My employer cares a lot about ways that our suppliers communicate their quality stance and the rigor of their certification(s) to us. I'm very interested in learning about ways that such communication can be shaded.
 
N

Nissim Shaked

Shaked
Re: Notified Body overflow use of Eudamed

One of my clients is
being under "attack of" a certain Notified Body (NB), this specific NB was very non-aggressive for the last 4 years.
But lately they become extremely aggressive,
Is there any way to learn if such a N.B. is expending its reports to Eudamed?
It seems that they are looking to "improve their image" as a "good" NB?
Does any one know how to get such a information?
thanks
Nissim
 
Ronen E

Ronen E

Problem Solver
Moderator
Re: Notified Body overflow use of Eudamed

Hi,

(a) Eudamed is currently not accessible to the general public.

(b) Officially, Eudamed is only supposed to be accessible to Competent Authorities (Member States), however, I think (not sure) that NBs have read-only access. The way NBs are supposed to contribute information to Eudamed is by reporting to their CA, which is supposed to upload as applicable. NBs are also required to communicate certain events (such as refusing a certificate) directly to all other NBs, not via Eudamed.

Cheers,
Ronen.
 
M

MIREGMGR

Re: Notified Body overflow use of Eudamed

Nissim Shaked said:
One of my clients is
being under "attack of" a certain Notified Body (NB), this specific NB was very non-aggressive for the last 4 years.
But lately they become extremely aggressive,
Is there any way to learn if such a N.B. is expending its reports to Eudamed?
It seems that they are looking to "improve their image" as a "good" NB?
Does any one know how to get such a information?
thanks
Nissim
Click to expand...

Does "very non-aggressive" mean that the NB used to turn a blind eye to large numbers of non-conformances, and "extremely aggressive" mean that the NB is now flagging everything they see?

If so, and if they were hired because they tended to not see things, I suppose it must be dismaying to have them suddenly become rigorous...but I'm not sympathetic.
 
N

Nissim Shaked

Shaked
Re: Notified Body excessive reporting onto Competent Authorities via the Eudamed data

This specific NB was not "blind"
Its audits were "average difficult" due to low level of auditing knowledge.
I do know that they were suspended by the central EU accreditation center
from approving any new medical devices.
The issue of my question is -that they become impossible to work with, regarding already approved devices.
By the way this clients quality is such that the average returning products in this company is about 0.7% per year !!,
and its sales are growing very well , so it is not an issue of a "weaselly company"
My question was: is there any information that I can learn from about the status of NB at the EU (on hold/under warning, etc..), since I am looking to move my clients products to another NB without any "NB political maneuvers".
I am not working with companies like what was hinted in the last post.
I am very much aware about my responsibility to deliver excellent products to the market !!
thanks
Nissim
 
P

pkost

Trusted Information Resource
Re: Notified Body excessive reporting onto Competent Authorities via the Eudamed data

There is nothing you can do to determine what information is being reported to the competent authority, however the following statements be made:
1. All notified bodies are increasing the rigour of their reviews of notified bodies​
2. All competent authorities are requiring an higher standard from their notified bodies​
3. If a notified body has had conditions placed on it's notification (i.e. it cannot issue new certificates) then there is a fundamental problem at the notified body. A perceived "high standard" of audit on the manufacturer by the manufacturer, is likely to be misplaced.​
4. all manufacturers and their technical files of said notified bodies are likely to come under an even finer review.​
5. A complaint rate of 0.7% is largely irrelevent without many more details such as the type of product and the type of complaints.​
​
Regardless, the CA may not have confidence in the product because of an inadequate review by the NB
 
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