This Q&A intends to clarify certain interfaces between the Regulation (EU) No 536/2014 on
clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on
in vitro diagnostic medical devices (IVDR). It was developed by clinical trials experts from
Clinical Trials Facilitation and Coordination Group (CTFG) and in vitro diagnostics experts
from the IVD sub-group of the Medical Device Coordination Group (MDCG). It has been
adopted by CTFG, the Clinical Trials Expert Group of the European Commission and
endorsed by the MDCG.
The need for interoperability of databases for clinical trials with medicinal products and
medical devices is laid down in the new Regulations, however, no further details on the
interface of IVDR and CTR are in the legislation, e.g. the requirements for assays used in the context of clinical trials…
