Notified Body - Definition - Who is the "notified body"?

[RCW]

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.

[Stijloor]

In Reply to Parent Post by RCW

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.

[Sidney Vianna]

http://ec.europa.eu/enterprise/newapproach/nando/

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.

[Al Rosen]

In Reply to Parent Post by RCW

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 here. There's nothing like going to the source for information.

[Roland Cooke]

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.