Production Validation- CE Mark

HnZul

Starting to get Involved
#1
Greetings!

We are doing product validation right now for Class IIa device. If we would like to get CE mark and product register in Europe, does anybody know if we need to do validation for all sizes of the device? Or we can just choose a worst case to represent all the sizes2.

Kindly help, we are not familiar with CE mark. Thank you in advance!
 
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shimonv

Trusted Information Resource
#2
You can to the validation on a representing case (worst case). Be sure to include explanation why it is a representative case.

Shimon
 

Mhalik

Starting to get Involved
#3
I confirm that what Simon said. You can use a worst case approach but make sure to add a real rationale to explain why you can extend your validation results to your other MD. Some notified body can be very challenging
 

HnZul

Starting to get Involved
#4
Thank you Both!
We are discussing either to select a worst case or to select low, middle, high to do product validation. So this mean how we justify is the crucial point.

Thank you.
 
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