Medical Devices and In-Vitro Diagnostics Used in Drug Clinical Trials: Principles of Use and Sponsor Responsibilities Under the Medical Device and IVD Regulations Requirements

Introduction
– Definition of combinations products
– Type of devices used in drug clinical trials
– Regulatory pathway

Clinical Trials with a CE-Marked device as delivery system
– Clinical development of the DDC
– Sponsor responsibilities

Combined Studies
– Definition
– Interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and medical device regulations (EU) MDR/IVDR
– Update on combined projects.

Takeaways

Dr. Fatima Bennai-Sanfourche, Bayer AG/Medtech & Pharma Platform, Germany

Dr. Fatima Bennai-Sanfourche currently serves as the Global Senior Director of QA&RA Compliance for Medical Devices, Combination Products, and eHealth at Bayer AG. In this role, she ensures regulatory compliance and high product quality across Bayer’s medical device and eHealth portfolio. She also oversees the compliant use of medical devices and software tools in clinical investigations and trials, adhering to Good Clinical Practice.

She has a rich background in the medical field, with over 20 years of experience in quality management, regulatory affairs, and the development of medical devices, including software, in vitro diagnostics, and combination products. Her career at Bayer began in the medical affairs and pharmacovigilance department, where she served as the Director of Medical Device Safety and Global Pharmacovigilance/Medical Device Safety Officer.

Her academic journey started with a focus on Biology, specialising in Biochemistry, Immunology, and Pharmacology. She earned her PhD in Pharmacology and Pharmacochemistry from Strasbourg, France. Dr. Fatima-Bennai-Sanfourche early professional life was dedicated to research and development in France, Sweden, and Germany, focusing on cerebrovascular diseases, hypertension regulation, and immunoassay development.

In addition to her current responsibilities, Dr. Fatima-Bennai-Sanfourche leads the implementation of the Medical Device Regulation (MDR) for PH-Bayer AG. She has been recognised for her expertise and contributions to the field, being nominated by the European Commission in 2019 as an EFPIA observer for the Post-Market Surveillance and Vigilance (PMSV) subgroup (GROW.D4). Since July 2021, she has been a member of the European Commission Post-Market Surveillance (PMS) task force, contributing to the preparation of MDR PMS guidance according to Article 83.

Dr. Fatima Bennai-Sanfourche is actively involved in several professional groups and initiatives, including:

Member of the Regulatory group of the EFPIA for medical devices.
Member of the EU Commission group for Clinical Investigation and Evaluation of medical devices (MDCG CIE).
Chair of the In vitro Diagnostic group at Medtech and Pharma Platform (MPP).
Member of the European Acceleration Clinical Trials (ACT EU) initiative chaired by the EMA.
Member of the ACT EU Multi-stakeholder Platform Advisory ad-hoc Group.
Member of the RWD used in pragmatic trial group at TransCelerate.

Her extensive experience and leadership in the pharmaceutical, medical device, and regulatory fields make her a pivotal figure in the Medtech and pharma regulatory landscape in Europe.