Theme Clinical trials using diagnostic tests
Target Audience Manufacturers and clinical trials sponsors
Products concerned IVD & medicines
Documents mentioned

Regulation (EU) 2017/746

Regulation (EU) No 536/2014

Directive 98/79/EC


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.