Using 2 different Notified Bodies

[aeropel]

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

 

[MIREGMGR]

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.

 

[somashekar]

Re: Use of 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

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Feel free to work with any other NB as your CE with your present NB is withdrawn.

 

[aeropel]

Re: Use of 2 different Notified Bodies

Thanks all for their prompt reply.

 

[renenatasha]

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

 

[somashekar]

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.

 

[Mark Meer]

Re: Use of 2 different Notified Bodies

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):

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...