Strategies for successful combined (drug/device) study approvals in the EU

In vitro diagnostic tests are a key component in clinical trials with investigational medicinal products (IMP). However, many of these tests are not CE-marked or not used in accordance with their CE-mark within clinical trials. Such tests, when used for patient management decisions in the EU, are governed by the EU In Vitro Diagnostic Regulation (IVDR) and require the regulatory status of either an ‘in-house device’ or a ‘device for performance study’. This presentation provides medical writers with an introduction to both regulatory statuses under IVDR.

In most cases however, only the status of ‘device for performance study’ is possible, necessitating the conduct of a device performance study in parallel with the clinical trial, i.e., necessitating a combined study. Obtaining approval for these performance studies from national competent authorities and ethics committees has proven to be a significant challenge, slowing down clinical trial enrollments in the EU. Medical writers are in the hot seat to help build the study submission packages for the different EU countries where combined studies are planned. This session will provide an overview of regulatory hurdles – and solutions – to obtain performance study approvals in different EU countries.

Anne Paulussen, Flen Health, Belgium

Anne Paulussen is a seasoned regulatory affairs expert with over a decade of experience spanning in vitro diagnostics (IVDs), combination products, and biotechnology. She specializes in strategic regulatory guidance for combined submissions of investigational drugs with investigational devices, with a strong focus on Companion Diagnostics (CDx) under the EU In Vitro Diagnostic Regulation (IVDR).

Anne has successfully guided start-ups bringing their IVDs to the EU market, and advised major pharmaceutical and diagnostic companies on Annex XIV IVDR applications. Her expertise extends to global regulatory strategy, FDA engagement, and clinical trial compliance and she is also an experienced speaker and trainer at industry conferences such as EMWA, RAPS and Healixia Clinical Trial conference.

Currently, Anne serves as Quality, Regulatory, and Clinical Affairs Director at Flen Health, overseeing a team navigating global regulatory challenges. As co-chair of RAPS Belgium LNG and a member of EMWA’s Medical Device SIG, she actively contributes to the regulatory community.

With a passion for knowledge-sharing and regulatory excellence, Anne is dedicated to helping companies bring innovative combination products and diagnostics to market while ensuring compliance with evolving regulations.

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.