The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > CE Marking (Conformité Européene) / CB Scheme
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Using 2 different Notified Bodies


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links that Cove visitors will find useful in your quest for knowledge:

International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC


NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags (Not all threads are Tagged)
ce mark and ce marking, certification bodies (cb), iso 9001 - quality management systems, notified body, technical files for medical devices
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 4th September 2013, 03:27 AM
aeropel

 
 
Total Posts: 35
Question Using 2 different Notified Bodies

I have my ISO 9001 + ISO 13485 + Canada from NB "a".
My CE marking (class IIa) expired and I have not done the 3rd edition testing yet so the NB "a" decided to withdraw the CE certificates for the products approved in the past. We are supposed to send them back the CE certificate. (that has already expired)
Question:
Can I apply for a CE mark to another NB after I complete my technical file?
This will man that NB "a" will certify me for the ISO issues and NB "b" will be the one for the CE (MDD 93/42) ?

Thanks

Sponsored Links
  Post Number #2  
Old 4th September 2013, 10:46 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: Use of 2 different Notified Bodies

Yes, you can, for forward going production. You will need to be prepared to answer probing questions from your customers etc. as to why, though.
Thanks to MIREGMGR for your informative Post and/or Attachment!
Sponsored Links

  Post Number #3  
Old 4th September 2013, 12:18 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,195
Re: Use of 2 different Notified Bodies

Quote:
In Reply to Parent Post by aeropel View Post

I have my ISO 9001 + ISO 13485 + Canada from NB "a".
My CE marking (class IIa) expired and I have not done the 3rd edition testing yet so the NB "a" decided to withdraw the CE certificates for the products approved in the past. We are supposed to send them back the CE certificate. (that has already expired)
Question:
Can I apply for a CE mark to another NB after I complete my technical file?
This will man that NB "a" will certify me for the ISO issues and NB "b" will be the one for the CE (MDD 93/42) ?

Thanks
ISO9k + ISO13485 + Canada is from a CB
Some CB's also are NB's
Feel free to work with any other NB as your CE with your present NB is withdrawn.
Thanks to somashekar for your informative Post and/or Attachment!
  Post Number #4  
Old 8th September 2013, 03:11 AM
aeropel

 
 
Total Posts: 35
Re: Use of 2 different Notified Bodies

Thanks all for their prompt reply.
  Post Number #5  
Old 9th April 2017, 09:52 AM
renenatasha's Avatar
renenatasha

 
 
Total Posts: 25
Please Help! Re: Use of 2 different Notified Bodies

Good day, Co-"lo"vers

I've similar questions too.

Is it possible to have 2 different NB for our EC certification (Class IIa product)?

For instance, our current NB issues us QMS cert + EC certs (both Is, and IIa above) but due to some reasons, we'd like to engage a new NB just for a particular product family (Class IIa). Will this cause any conflict?

Please advise. Thanks - Rene
  Post Number #6  
Old 9th April 2017, 11:58 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,195
Re: Use of 2 different Notified Bodies

You can have two different NB for two different products. Make sure that the same product is not notified by two NB.
Thanks to somashekar for your informative Post and/or Attachment!
  Post Number #7  
Old 10th April 2017, 01:12 PM
Mark Meer

 
 
Total Posts: 586
Re: Use of 2 different Notified Bodies

Quote:
Is it possible to have 2 different NB for our EC certification (Class IIa product)?
As Somashekar says, ok...just make certain it's not for the same product - the Directive explicitly forbids this.

For example, Annex V (3.1):
Quote:
The manufacturer must lodge an application for assessment of his quality system with a notified body.
The application must include:... a written declaration that no application has been lodged with any other notified body for the same products...
Thanks to Mark Meer for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > CE Marking (Conformité Européene) / CB Scheme

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
What's the big picture on Notified Bodies? Julie O EU Medical Device Regulations 4 11th July 2016 06:39 AM
Notified Bodies Backed Up? QM Becky EU Medical Device Regulations 19 7th June 2016 11:49 PM
If NB's (notified bodies) cannot be trusted how can we? rob73 EU Medical Device Regulations 39 27th May 2014 07:04 PM
New EU approach to notified bodies Gert Sorensen Other ISO and International Standards and European Regulations 0 29th April 2011 01:32 AM



The time now is 09:54 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 


NOTE: This forum uses "Cookies" - A Peachfarm Internet Property