Q&A on the Interface between Regulation (EU) 536/2014 on Clinical Trials for Medicinal Products for Human Use (CTR) and Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices (IVDR)

On 25 May 2022 the European Commission published Q&A guidance on the interface between the EU CTR and IVDR.

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).

This Q&A specifically addresses the use of assays in the framework of clinical trials conducted under the CTR, in line with requirements of the IVDR and should not be understood to apply beyond it.

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