Clinical
Clinical investigations under MDR: key insights and practical experiences
This whitepaper provides insights on:
- the ongoing harmonization in the authorization process by regulatory authorities and ethics committees,
- the evolving role of the EU Legal Representative for sponsors outside Europe,
- the influence of MDR on study conduct, with stricter requirements for safety reporting and post-market surveillance and future developments, including the integration of EUDAMED and the coordinated assessment procedure
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About the authors
Our whitepapers are created by experts with real-world experience and deep industry knowledge.
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Tineke Scheers
Tineke holds a PhD in Biomedical sciences and has over 12 years of experience in clinical research, particularly within the medical device sector. She has a robust background in various facets of clinical operations. Throughout her career, Tineke has primarily served as a Project Manager, where she played a role in the successful execution of numerous pre- and post-market clinical investigations. Tineke’s expertise includes the preparation and submission of clinical investigation applications to regulatory authorities and ethics committees, ensuring that all regulatory requirements are met with precision and adherence to the highest standards. Recently, Tineke has transitioned into the field of medical writing, where she is leveraging her extensive clinical research experience.
Sarah Andries
Sarah studied Biomedical Science at the University of Antwerp, specializing in clinical research. She started at the University Hospital Cardiology department where she gained clinical and medical experience. As a first step into the life science sector, she started as a study coordinator in a clinical trial phase 1 unit. Since 2013 she worked in the CRO environment focusing on medical device investigations and has been working in clinical regulatory for almost 10 years. This has led to extensive experience in clinical study applications to regulatory authorities, ethics committees and other applicable bodies across Europe and beyond. Sarah is currently head of the clinical regulatory team at QbD Clinical.