On going Stability for IVDs

ernieto

Starting to get Involved
#1
Don't know if this is the right forum.

Is there any requirement for ongoing or post-approval stability for IVDs? Looking for what is the requirement through FDA and EU? Thanks
 

ernieto

Starting to get Involved
#4
Thanks for the reply. I have that document and I also use ISO 23640:2011 In vitro diagnostic medical devices: Evaluation of stability. Do you now where FDA or EU mentions that is required?
 

invitro_spain

Involved In Discussions
#5
Hi Ernieto,

I think the best standard for the US is the CLSI EP25a as QAengineer said. In any case, the relationship between the CLSI and the European Harmonized standards is acceptable.
 

QAengineer13

Quite Involved in Discussions
#6
Thanks for the reply. I have that document and I also use ISO 23640:2011 In vitro diagnostic medical devices: Evaluation of stability. Do you now where FDA or EU mentions that is required?
Its an implied requirement from the FDA /EU or any regulatory agency because the Requirement for PERFORMANCE OF SAFE & EFFECTIVE medical device/IVD is part of the essential requirements, so I would say the stability is one of the key requirements that could be used to strengthen your performance claims of the marketed device.
 

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