Can a non-CE marked, non-FDA approved IVD be used in a phase III clinical trial. I am very new to this sort of regulatory landscape so any pointers to relevant regulations would be greatly received. Many thanks.
Thanks Ronen. Yes the clinical trial will be done in the US. Just to clarify that this is a drug clinical trial, the IVD/MD will just be a component of the trial and only acts as an accessory. The IVD/MD in question is a software package and I'm not sure how it will be classified in the FDA system. Currently in the EU for CE marking it is classed as low risk.