Which Notified Body to Choose in the EU

Remus

Involved In Discussions
#1
Hello, at September 2013 European commission published recommendations for Notified bodies. After that European Commission started to audit Notified Bodies. As a result of this audits some of Notified Bodies accredition withdrawn and others got expiry dates.

All of the products, The company I worked, are OBL and all of the OEM companies have diffrent NB'ies. And EC havent controlled our NB yet, and in my opion they will lose their accreditation or they will get expiry date. So what shall I do? Where can I see the NB audit results? Its very important for me because we have around 90 Technical File and If our NB lose their accretitaion we cant get a new one in short time.
 
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NikkiQSM

Quite Involved in Discussions
#2
Transfer to another NB. Doing it now is best if you fear your current NB will lose their accred.

You would have to provide some documentation and they will have to review your current certification - but starting now is best before you find out its too late.

Here is some info I found:

Prerequisites for Transferring Notified Bodies
To transfer notified bodies, a manufacturer should have some documents and certificates at the ready for the new notified body to validate. Additionally, there are a few more prerequisites for a manufacturer or distributor to transfer notified bodies. To transfer notified bodies, the manufacturer or distributor must have:

  • Valid certificates for the products;
  • The address for the manufacturing sites, which must be the same as those on the valid certificates;
  • The devices must be within the same scope of the previous certificates;
  • There must be no threat to the certificates, meaning the certificates must not be predicated on fixing non-conformities; and
  • Enough time to transfer the certificates.[6]
It is reasonable to assume, however, that some manufacturers may not have all these necessary documents. [Contact us] to talk to one of our expert technical staff for more information on how to transfer notified bodies.
Important Documents to Include
When transferring notified bodies, the manufacturer should include in their file:

  • All current cycle audit reports from the previous notified body;
  • All certificates for the product that will be transferred;
  • A letter from the manufacturer authorizing the transfer;
  • A report of any non-conformities and the action plan to fix any non-conformities; and
  • A report of any adverse events, like customer complaints and recalls, since the last audit.
These documents will give the new notified body a full view of the product and the previous assessments in order to best provide manufacturers and authorized representatives a full view of the services that the new notified body can offer. Even though this may raise the price of transferring for the manufacturer, further proof of a conforming product is never a bad thing for the manufacturer’s bottom line.
 

Sarah Stec

Involved In Discussions
#3
The NB audit reports aren't publicly available. If you are worried about whether or not your NB is going to make it in the end, you may want to look into transferring sooner rather than later.

The info that Nikki gave above is correct (it's one of my NB's publications :agree1:), and another document you can look at is the NBOG Best Practices Guide for transferring notified bodies. It gives some information about what should happen when an NB loses its notification.
 

Remus

Involved In Discussions
#6
I have just changed my job, in my old job I have worked with several notified bodies. Now in my new company everything is much easier :) But it shouldn't be after 2013 EC Recommendations. Anyway they will be auidit soon.
 

pkost

Trusted Information Resource
#7
There are many different notified bodies, with many different standards (I know they should all be the same), some better than others. The notified bodies that have had their status withdrawn were notoriously. I would hope that if an NB is salvagable the competent authority would issue correctiv actions and give them an opportunity to improve

I don't know your exact circumstances, but I would want pretty convincing evidence of an imminent failure before approving a change of NB for 90 technical files...If I were to move 90 of my technical files the project costs would easily run into 7 figures, 8 would not be a surprise. (resource, artwork, printing, supply chain management, write off etc. etc.)

Is there nothing you can do to reassure yourself? Arrange a meeting with the NB at their head office - discuss with them your concerns and ask them what they are doing to protect their business from the changing regulatory environment?

As a new employee, If you change notified body, incur massive costs on the basis of a potential failure, then in 12 months the notified body is still up and running and your new NB is much stricter, I would not like to bet on your chances of working for that company for another 12 months!
 

Remus

Involved In Discussions
#8
I have talked with top management, I have explained the situation. We decide to w8, their audit. The good thing is most of our prodcuts are OBL, and also we can sell them as distributors.

So I am w8ing now, but I start to update technical files.
 
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