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Notified Body - Definition - Who is the "notified body"?
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Notified Body - Definition - Who is the "notified body"?
Notified Body - Definition - Who is the "notified body"?
Notified Body - Definition - Who is the "notified body"?
Notified Body - Definition - Who is the "notified body"?
Notified Body - Definition - Who is the "notified body"?
Notified Body - Definition - Who is the "notified body"?
Notified Body - Definition - Who is the "notified body"?
Notified Body - Definition - Who is the "notified body"?
Notified Body - Definition - Who is the "notified body"?
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  Post Number #1  
Old 14th April 2009, 11:47 AM
RCW's Avatar
RCW

 
 
Total Posts: 472
Question Notified Body - Definition - Who is the "notified body"?

What is the definition of and/or who is the "notified body"?

Does this just relate to CE marking and maybe the FDA?

Is my registrar a notified body? (My registrar has only issued me certificates for ISO 9001 & ISO 13485. No CE work or anything else.)

I'm hearing lots of different definitions from several people here. I'd like to hear some more from some people who might actually have a clue.

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  Post Number #2  
Old 14th April 2009, 12:03 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,195
Re: Definition of "Notified Body"

Quote:
In Reply to Parent Post by RCW View Post

What is the definition of and/or who is the "notified body"?

Does this just relate to CE marking and maybe the FDA?

Is my registrar a notified body? (My registrar has only issued me certificates for ISO 9001 & ISO 13485. No CE work or anything else.)

I'm hearing lots of different definitions from several people here. I'd like to hear some more from some people who might actually have a clue.
This may help.

Stijloor.
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  Post Number #3  
Old 14th April 2009, 12:04 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,794
Re: Definition of "Notified Body"

Quote:
Notification is an act whereby a Member State informs the Commission and the other Member States that a body, which fulfils the relevant requirements, has been designated to carry out conformity assessment according to a directive. Notification of Notified Bodies and their withdrawal are the responsibility of the notifying Member State.

The Member States, EFTA countries (EEA members) and other countries with which the EC has concluded Mutual Recognition Agreements (MRAs) and Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECAs) have designated Notified Bodies, established per directive. Lists of Notified Bodies can be searched on the NANDO web site. The lists include the identification number of each notified body as well as the tasks for which it has been notified, and are subject to regular update.
Notified Bodies are authorized by the Notifying Authorities.

Last edited by Marc; 1st August 2017 at 01:00 PM. Reason: Dead links removed.
  Post Number #4  
Old 14th April 2009, 12:13 PM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,559
Re: Definition of "Notified Body"

Quote:
In Reply to Parent Post by RCW View Post

What is the definition of and/or who is the "notified body"?

Does this just relate to CE marking and maybe the FDA?

Is my registrar a notified body? (My registrar has only issued me certificates for ISO 9001 & ISO 13485. No CE work or anything else.)

I'm hearing lots of different definitions from several people here. I'd like to hear some more from some people who might actually have a clue.
Each directive has a group of notified bodies within the EU. You can find the list <Dead link removed>. There's nothing like going to the source for information.

Last edited by Marc; 1st August 2017 at 01:08 PM. Reason: Dead link removed.
  Post Number #5  
Old 14th April 2009, 02:10 PM
Roland Cooke

 
 
Total Posts: 613
Re: Notified Body - Definition - Who is the "notified body"?

See my footer.

Keeping it real simple....

A Registrar issues ISO certificates. Not all registrars can issue the same types of ISO certificates.

A Notified Body issues EC certificates. Not all Notified Bodies can issue the same types of EC certificates, and even if they can, there are often government-mandated limitations as to what the content can be (i.e. by product technology in the case of medical devices)

Most, perhaps all, Notified Bodies are also Registrars, but there isn't a requirement for that. Most Registrars are not, however, also Notified Bodies.

Now both Registrars and Notified Bodies are examples of third-party certification organizations. There are many others. Almost all are commercial operations, unlike say, the FDA.

That said, there is a third-party certification scheme controlled by FDA, so SGS can indeed do some work on behalf of FDA, at the request/option of a manufacturer. We would be paid by the manufacturer for our efforts.

There is also a third-party scheme controlled by the MHLW/PDMA in Japan, so again SGS offers services for that.

And so on. I hope that makes sense.
Thanks to Roland Cooke for your informative Post and/or Attachment!
  Post Number #6  
Old 1st August 2017, 01:07 PM
Marc's Avatar
Marc

 
 
Total Posts: 25,853
Re: Definition of "Notified Body"

This thread had a bunch of dead links. Can anyone here please help by adding some links to current pages? My Thanks in advance.
  Post Number #7  
Old 1st August 2017, 01:13 PM
JeantheBigone

 
 
Total Posts: 128
Re: Notified Body - Definition - Who is the "notified body"?

A resource on Notified Bodies:

https://ec.europa.eu/growth/single-m...fied-bodies_en
Thanks to JeantheBigone for your informative Post and/or Attachment!
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