Nanotechnology-based MD & IVD Roadmap to EU registration per MDR 2017/745 & IVDR 2017/746
The regulatory roadmap for the European registration of nanotechnology-based medical devices and IVDs is presented. This regulatory roadmap is the same for conventional medical devices and IVDs as for nanotechnology-based medical devices or IVDs.
However, for the latter additional analytical performance characterization, risk management and labelling are required. The different regulatory steps are highlighted, as well as the current challenges, such as incomplete intended purpose statements and what is sufficient clinical evidence. Many small medical device and IVD companies are not well prepared for the transition to the new regulatory requirements.
The key steps of the regulatory roadmap are reviewed: Manufacturer’s role, scientific validity, analytical performance, clinical performance, clinical evidence, clinical performance report, post-market clinical follow-up, conformity assessment, GSPRs, certificates and EUDAMED registration.
Participants will learn what the required regulatory steps are for the development of a nanotechnology-based medical device and IVD in compliance with the MDR and IVDR regulations.
When you are developing nanotechnology-based devices this webinar is a must for you to stay compliant with the current regulations
Luc Van Hove,
MD, Ph.D, CEO MARACA International
Luc Van Hove is a MD, PhD, Clinical Pathologist and Clinical Study Physician with more than 25-years’ experience in Medical Device, In vitro Diagnostic (IVD) Device, Molecular Diagnostics and Companion Diagnostics development, clinical registration study management and registrations of Medical Devices and IVD devices in Europe, the US and other countries. Luc founded and is CEO of MARACA International, BV, Belgium, a consulting firm for Medical, Regulatory and Clinical Affairs services with global reach. Luc is focused on global clinical and regulatory advice for nanotechnology-based medical devices and Companion Diagnostic development, clinical studies and registrations, servicing pharma, Medical Device, IVD companies and clinical laboratories.
Luc Van Hove was previously working for more than 20 years as Clinical and Regulatory expert for IVD companies in Europe and the US. Luc was Medical Director for 15 years at Abbott Laboratories, Chicago, a fortune 500 company, and had worldwide medical, clinical and regulatory responsibilities for all diagnostic products. Luc jointed thereafter small US and European biotech companies to lead their Clinical and Regulatory Departments as Senior Director, Vice President or Chief Medical Officer. Most recently Luc worked for Biocartis, Belgium. Therefore, he worked for Asuragen and Exagen in Austin, Texas.
Luc Van Hove is a board-certified Clinical Pathologist (Klinisch Bioloog) in Belgium, Europe. He studied at the KULeuven, Belgium, to achieve his medical degree (MD), his PhD in tumor immunology and his specialty degree as Klinisch Bioloog. During these years, Luc was also a Fellow of the Belgian National Fund for Scientific Research (NFWO) with his oncology work and advanced to Associated Professor. Luc published more than 150 papers, many in the oncology field and more recently in Molecular Diagnostics. He is awarded by the American Association for Clinical Chemistry (AACC) and by Abbott Laboratories. Luc is active in clinical and regulatory societies and in clinical standardization bodies.