2022-05
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 trial 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.
Assays used in clinical trials may range from CE marked in vitro diagnostic medical devices (IVDs) to trial- or medicinal product-specific assays that are not always meant to be developed as IVDs. The need to clarify requirements for these assays lead to the Q&A and the concept of the “medical purpose of an assay in a clinical trial” as a specific setting.
The document can be downloaded from our library
Source: European Commission