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IVD - Generating clinical data for IVD’s in the EU

MiamiDM

Starting to get Involved
#1
I hope you’ll be able to provide some advice.

Could you point me in the direction of useful guidance documents / articles that detail requirements / the process for generating clinical data for IVD’s in the EU.

I am familiar with the process for obtaining pre market and post CE approval clinical data for devices, but am unsure how IVD’s compare.

Many thanks
:thanx:
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
Hi, the rules for testing IVDs under the current IVD Directive are very different from those for devices. They are generally referred to as Devices for Performance Evaluation. Take a look at Annex VIII of the 98/79/EC directive.
Chris
 
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