Notified Body Loses Designation

mpfizer

Involved In Discussions
#1
what is the procedure to be followed if a notified body who has issued a CE certficate is denotified or loses its designation?

what is the time period to get re certfied with another body and are there any rules or directives governing this .

Thanks

Michelle
 
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pkost

Trusted Information Resource
#2
Re: Notified Body Looses Designation

I'll be honest and say I'm not sure...there would be a couple of different responses depending on the delisting

1. the competent authority phases out the existing certification (i.e. gives a grace period of the remaining period of time for the certificate). In this circumstance you need to find a new NB as soon as possible....

2. If the CA decides that the NB's actions pose a high risk the existing certificates issues by the NB will be invalid immediately. In this case:
a. find a new NB as soon as possible
b. If your device is particularly novel and its removal from the market presents a risk to public health and safety, you can approach the competent authorities for exceptional permission to market a non-CE marked device.

Beware however that your notified body was delisted for a reason...it's likely they were accepting things that shouldn't be accepted, therefore your systems and technical documentation may not be as robust as you believe
 
M

MIREGMGR

#3
I don't have any relevant experience, but everything that PKost says above I'm sure is right. I would add: I think your questions are best asked of your national CA, ASAP. I don't think this is an area where there is a uniform process.
 
S

Sarah Stec

#4
There's an NBOG Guidance document that explains the process - if you search for "change of notified body NBOG" it should pop up as one of the first results. If your notified body loses its designation, then it's an "involuntary" change. The Guidance Document gives the broad strokes, and I've seen there be a bit of leeway between competent authorities with the details of how it works. Has your current notified body corresponded with you regarding how it's going to be handled?
 
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