|Clinical trials using diagnostic tests
|Manufacturers and clinical trials sponsors
|IVD & medicines
Regulation (EU) 2017/746
Regulation (EU) No 536/2014
This guide provides questions and answers to clarify how the following two regulations: regulation (EU) 536/2014 on clinical trials of medicinal products for human use and regulation (EU) 2017/746 on IVDDs, in the case of clinical trials using diagnostic tests including combined trials for the development of companion diagnostics.
Non-interventional studies are considered outside the scope of this guide.