Companion diagnostics (CDx) play a crucial role in precision medicine by identifying patients most likely to benefit from specific therapies. Under the EU In Vitro Diagnostic Regulation (IVDR), CDx are classified as class C devices, and conformity assessment for market approval requires interaction with both Notified Body (NB) and EMA for medicinal products. This presentation provides medical writers with an introduction to CDx under IVDR.
Prior to seeking market approval, the CDx must be evaluated for its performance, typically in a clinical trial. Conducting combined studies, that assess both an investigational medicinal product (IMP) and a CDx in a single trial, has proven to be a major challenge in the EU. While the Clinical Trials Regulation (CTR) governs IMPs, CDx fall under IVDR, requiring separate but interdependent regulatory approvals. Medical writers play a vital role in aligning documentation for competent authorities, ethics committees, ensuring consistency and compliance. This session will simplify the often-complex regulatory requirements and help medical writers to contribute effectively in getting approvals for the use of CDx in combined studies, supporting precision medicine and patient access to innovative therapies.
Medical Writers’ Guide to Companion Diagnostics Under IVDR and Combined Studies in the EU
Pieter Bogaert, QbD Group, Belgium
Pieter holds a PhD in Biotechnology with an academic career as molecular immunologist and a technical expertise in flow cytometry. He became an in vitro diagnostics (IVD) consultant after holding several positions at an IVD manufacturer and a central laboratory contract research organisation (CRO) for clinical trials. At QbD Group, Pieter is currently a senior regulatory affairs consultant, specialised in IVD regulation, and ISO 13485 lead auditor. He supports IVD manufacturers from start-up companies to multinationals, as well as laboratories, in complying with Quality Management Systems (QMS) and IVD Regulation (IVDR) requirements. Pieter is also in the leadership team of the Belgian RAPS Local Networking Group.