Do clinical performance studies for IVDs need to be conducted in a member state?

A

ashishdaga

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#1
#1
We're an IVD Manufacturer based out of India. Our product falls under Class C. We're preparing to go ahead with CE Marking under IVDR eventually. We're still not sure if we can perform the Clinical Performance evaluation in India and use the data for the application, or is it necessary to perform the study in a member state or a member approved state.
 
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ECHO

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#2
#2
I am not sure if you have to perform the study in a member state but I do know you have to show that the demographic you are doing the study with is representative of the EU. So if you only do the clinical study in India, that might be a concern. But depending on the device/intended use, you might be able to justify your way out of it.
 
A

ashishdaga

Registered
#3
#3
ECHO said:
I am not sure if you have to perform the study in a member state but I do know you have to show that the demographic you are doing the study with is representative of the EU. So if you only do the clinical study in India, that might be a concern. But depending on the device/intended use, you might be able to justify your way out of it.
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Thanks!
 
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