Technical Documentation

B

Bernan_L

Registered
Hello all,
Is it customary to require a corrective action for findings of the Technical documentation for New Representation Client Review? My company has recently been required to provide one for missing documents that we already have and were not submitted during the initial review.
 
Y

yodon

Leader
Super Moderator
I need some help understanding. First, what's a "New Representation Client Review"? Is this a Notified Body?

Why wasn't the material provided in the first place? Seems like an appropriate corrective action would be to just give them the docs, since you say they already exist.
 
B

Bernan_L

Registered
yodon said:
I need some help understanding. First, what's a "New Representation Client Review"? Is this a Notified Body? For us to sell our products in the EU countries which were manufactured outside the EU, we must have an authorized representative in the EU (an EU Rep) to support the import process.

Why wasn't the material provided in the first place? Seems like an appropriate corrective action would be to just give them the docs, since you say they already exist.
Click to expand...
> We are planning on doing that eventually. I wanted to find out if anyone else on here is familiar with the process. Thank you.
 
C

Cloud808

Registered
Bernan_L said:
familiar with the process.
Click to expand...

I agree with yodon, in that I am not sure what process you are referring to. Does your notified body use this nomenclature?

If the "New representation client review" is the process of applying to a notified body, then I couldn't imagine any corrective action being required.

If this mystery process is an initial assessment of the technical documentation for MDR/IVDR conformity, I can offer that we have gone through a couple rounds of initial TD review and responded to additional information requests outside of the CAPA system, which were accepted by the NB. (Though as I understand it, every NB may operate slightly differently and it is effectively "their way or the highway" in some cases).
 
Orca1

Orca1

Involved In Discussions
Bernan_L said:
Hello all,
Is it customary to require a corrective action for findings of the Technical documentation for New Representation Client Review? My company has recently been required to provide one for missing documents that we already have and were not submitted during the initial review.
Click to expand...

It's not uncommon for a notified body to require correction actions for findings in the technical documentation during a review.
 
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