Review of Technical File for CE mark

JoCam

Trusted Information Resource
Hi All,

When a Certified Body auditor has completed reviewing a Technical File for either a new product, or extension to scope, I understand that they inform the client immediately of the outcome, which could either be details of the corrective actions raised, or recommendation for CE marking of the product. In the latter situation, can the client begin to sell the CE marked product right away, or do they have to wait until the auditors report has been reviewed, all paperwork completed and they have a copy of the certificate in their hands?

Regards,

JoCam
 

Pads38

Moderator
We have had Tech File review, received the OK from the auditor (by phone) signed the DoC and immediately started marketing.

The Notified Body certificate, showing the extension to scope, followed several weeks later. The delay was due to their head office taking time to process things.
 

JoCam

Trusted Information Resource
Hi Pads38,

This is pretty much what our auditor implied, but not in writing. Before I chase him I wanted to check what others had experienced, or if it is stated in ISO 17021.

Thank you,

JoCam
 

RobertvanBoxtel

Involved In Discussions
Unfortunately, you will have to wait until you have received the formal (electronic) version of the certificate(s). Even when your auditor / project manager indicates that all is fine, the internal processing at NB's takes time and it will mean that your initial validity date will be different from when your NB contact said all was ok.
 
S

sarahstec

I agree that you should wait. At the NBs I know of, the additional process isn't just admin but additional checks on the auditor and reviewer - the NB is claiming your device is OK, so they're going to cover all their bases, even if that means going back and asking you for more information after the reviewer is finished (which, while uncommon, isn't unheard of).
 

paulag

Involved In Discussions
And don't forget to notify the national competent authority before placing the device on the market...
 
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