This Q&A intends to clarify certain interfaces between both following regulations:
- the Regulation (EU) No 536/2014 on clinical trials for medicinal products for human use (CTR)
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
This Q&A provides clarification on the regulatory status of assays performed on human samples used in the context of clinical trials as well as on the regulatory expectations toward the clinical trial sponsors.
The overall aim is to support the conduct of clinical trials using diagnostic assays, including combined trials for the development of companion diagnostics (CDx).