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

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
