IMDRF 2023

24th session

25-26 September 2023 | Berlin, Germany

Leo Hovestadt

EU Director Governmental Affairs, Elekta

Leo Hovestadt is EU Director Governmental Affairs, with more than 30 years of experience in the medical device industry at Elekta and Medtronic. Prior to his current position, Leo worked as International QA and RA director.

He was closely involved from the start with the FDA QSR, the EU (AI)MDD and the EU MDR. He is representing industry as stakeholder during the creation of EU MDCG and international IMDRF guidance. He is chairing COCIR (EU MDR), NEN (ISO standards) and DITTA (International guidance) work groups dealing with topics such as clinical investigation / evaluation, artificial intelligence, software as a medical device, risk management, interoperability, EMA and classification.

He is a regular speaker at congresses and (co-)authored regulatory and scientific publications.