Valid NB Technical Review Nonconformance? New Class IIb Product

pkost

Trusted Information Resource
#1
We had a technical review for a new class IIb product last week and it was kicked back because we did not state whether we marketed the device outside of the EU.

I maintain that this is not relevent to the review however they are persisting that we must inform them before they will approve the device. Does anyone have any experience with this/any suggestions? Are they actually justified in asking this?

Yes we can tell them however it's the principle if we are not required to!
 
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R

rclanzillotto

#2
I believe it is a valid request due to Medical Device Vigilance. Incidents occurring outside the EEC need be reported to the Competent Body in the country of whatever NB you are using. Its just information gathering but...IMHO it is valid
 

pkost

Trusted Information Resource
#3
Surely then the question should be...have you had any medical device incidents in relation to this device? and a check to ensure that your vigilance procedure includes reporting as necessary/required? Asking whether you market outside of the EC does not answer whether there has been any incidents that need reporting
 
M

MIREGMGR

#4
Asking whether you market outside of the EC does not answer whether there has been any incidents that need reporting
The question relates to the NB's simple ability to know whether your post market activities and reports correspond to everywhere you market. Clearly they are required to know this information under the appropriate Annexes.

And, there'd be no point to being adversarial even if you were right. All that "standing on principle" does is raise questions as to why you aren't cooperative. In most such instances, there's something that the business doesn't want the auditors to know.

Your NB works for you. If you don't think they're doing their job right, fire them and hire someone else.

In this particular instance, though, it won't do you any good, because the next one is very likely to ask the same question.
 

pkost

Trusted Information Resource
#5
I'd disagree that there is little point in being adversarial when they are wrong. You are right that you can just move, but it is somewhat expensive and prohibitive.

Does it mean that we are hiding something? No, it means that we believe in working to the regulations. But that being said we are more than willing to give information to the NB outside the requirements to assist them if it is a request and not demanded!

The concensus seems to be that they can demand the infomation above so we will duly include it in some form in future submissions!
 
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