CE Certificate Expiring and NB unable to extend / renew as not in their scope as a NB

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Bigdubz61

#22
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

We are a small company that holds an OBL Medical Device EC Certificate for some class IIa and IIb devices. Our certificate is due to expire shortly and we have been trying to renew / extend it. Unfortunately our NB (AMTAC / Intertek) has been ignoring our correspondence since April.

We then recently wrote to the MHRA who contacted our NB and all of a sudden the NB emailed to say that they could not issue a new certificate as this was no longer within their scope of designation as a NB but " We are working closely with MHRA to determine the way forward for the transition."

Has anyone had experience of this? We are now stuck trying to migrate to a new NB with only a few weeks before our current certificate expires.

Many thanks

Alan
Hi Alan.
I have had almost exactly that experience. Intertek (AMTAC) wrote to tell me that they can no longer handle OBL certifications. This did put us in a bit of a spot as the need to find a new NB became very apparent. Panic is now subsiding as we are moving our NB services to BSI. I hope you manage to sort yourself out. Keep in mind that some NBs (SGS for example) are not taking new clients. Good luck..
 

shimonv

Trusted Information Resource
#23
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Steve,
Why did they add the warning symbol? I don't see any limitation in the report.

Thanks,
Shimon
 
S

SteveK

#24
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Hi Simon,

It would appear the scope of the report has not been updated since 15/07/2014, but the warning symbol is current. Not actually seen the information that goes with the symbol before. Usually the NANDO site uses that symbol when the certificate has expired or been withdrawn, so your guess is as good as mine.

Steve
 
T

Tatian

#25
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Our problem is a little bit different.

The medical device remains in our notified body scope (as per NANDO and NB information). But 3 months before our CE mark certificate expires, the NB informed that they wouldn't have personnel to conduct the audit for CE mark. So, we are looking for a new NB but aware that the transfer will not occur in time. :mad:

I was looking for information regarding the NB liability and certificate expiry extension in this situation, but I haven't found anything (NBOG, TEAM NB, Blue Guide). What can I do in this situation?:frust:

Appreciate any contribution.


Contributing to previous posts:
1) Certificate expiry date extension in case of “Orphaned” manufacturers due to “denotified" Notified Bodies:
https://www.emergogroup.com/blog/20...-roadmap-manufacturers-european-notified-body

2) BREXIT
http://raps.org/Regulatory-Focus/Ne...-BSI-Says-it-Will-Remain-an-EU-Notified-Body/
https://www.emergogroup.com/blog/20...hat-does-mean-europes-medical-device-industry
 
Last edited by a moderator:

pkost

Trusted Information Resource
#26
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Your options are much the same as those who were told that the NB would no longer provide the service - essentially manufacture and place as much stock on the market as possible before the certificate expires!

There is no option to extend the certificate because the NB does not have the competence to assess whether the products listed are in compliance with the directive
 
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Sarah Stec

#27
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

I was looking for information regarding the NB liability and certificate expiry extension in this situation, but I haven't found anything (NBOG, TEAM NB, Blue Guide). What can I do in this situation?
You may also want to talk to a lawyer about this to know your options. Liability is very fact- and jurisdiction-specific, so it really depends on your specific situation. They may not be able to help much in the short term with forcing your NB to do anything, but they may help you understand your options.

:2cents:
 

Remus

Involved In Discussions
#29
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Actually, every Component Authority have different solutions, best way is to talk with your NB's component Authority, or the Component Authorities you have marketed your product.

For instance Germany may or may not recognize France guidance.

For instance, Italy allows one of its nondesignated NB to issue Certificate...!
 
T

Tatian

#30
Re: CE Certificate Expiring and NB unable to extend / renew as not in their scope as

Thank you very much for the replies.

We are surely going to talk to our lawyers, just waiting to see how things are going to evolve.

Regarding the consequences of the certificate expire, I would like to understand more to put in practice pkost's tip. Everything that's already on the market when the certificate expire may stay on the market, right? What about what's on my stock, since it has been manufactured under the certificate validity? Can anyone point the legislation where I can find this information?
 
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