Luc Van Hove is a clinical study physician with more than 25-years’ experience in MD, IVD, diagnostics development, clinical study management and device registrations.

Before founding MARACA in 2017, Luc previously worked for more than 20 years as a clinical and regulatory expert for IVD companies in Europe and the US. He was also medical director for 15 years at Abbott Laboratories 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.

A board-certified Clinical Pathologist in Belgium, he studied at the KULeuven to achieve his medical degree, his PhD in tumor immunology and his medical specialty as Klinisch Bioloog. During these years, he was also a Fellow of the Belgian National Fund for Scientific Research (NFWO) with his oncology research 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 explains that MARACA is currently especially focused on supporting medical device and IVD companies with the introduction of nanotechnology-based devices to the European and American markets. MARACA became the regulatory partner of the European Open Innovation Test Bed for the introduction of nanotechnology-based MDs, called Safe-N-Medtech.

“MARACA is developing a SME roadmap for the introduction of nanotechnology-based MD to the European market. Nanoparticle (NP) containing MDs need to follow the same regulatory path as the other MDs. But there are additional specific requirements for NP-based MD due to the new specific risks which NP could pose to the patient, the user or the environment. Therefore, additional specific biological toxicity studies need to be performed. For some of these NP devices special competent authority permission will be required and there can be additional labeling requirements needed for these devices.”

MARACA has organized a scientific session at the upcoming Regulatory Affairs Professionals Society (RAPS) European Convergence meeting in Brussels 26-28 October 2020. This session reviews regulatory hurdles to overcome to introduce nanotechnology-based IVD and MDs to the EU Market, as a Safe-N-Medtech concern. We will review the hurdles which NP devices have to tackle and what support the Safenmt consortium can offer to overcome these challenges.