Speakers Introduction

Rolf Oberlin Hansen is a Senior Advisor at The Danish Medicines Agency at the Unit for Medical Devices. He works for national implementation of software and AI related legislation and guidance, as he has been following the AI Act since its inception and provided sectorial input throughout the trilogue negotiations of it.
He is also heavily involved in these areas at both EU level, where he co-chairs the working group for developing AI Act guidance for the medical devices sector, and at International level as an active member of IMDRF working groups related to these topics, representing the EU.