Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201

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Belen Sanchez

Starting to get Involved
#2
About this issue I have a question, because the medical devices made by us are so bigger, our facilities no have space to assembly them and do a final verification/validation; each device is shipped in separated moduls and when the device is installed at hospìtal, the moduls are assemblied.

For this reason, verification is done on each modul, but there is not a validation of assemblied device in production. My question is that until now this situation is correct for our Notified Body, but it tells us that this situation can no be posible with the new 745/2017 Medical Device Rule, i'm not sure about it.
 

Marcelo

Inactive Registered Visitor
#3
Hi, I 'm not sure if this questions has anything to do with combination products (which is the focus of the guidance document posted), but anyway, "verification/validation"in the place of operation is always accepted for products which needs to be verified/validated there. The MDRQ does not change this (nor it should).
 
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