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EU Regulations for Medical Devices and In Vitro Diagnostics

Activity: Participating in or organising an event types › Participating in a conference, workshop, ...

Description

This webinar, organized by the BioPhot Platform, provided an overview of the European Union regulatory framework for medical devices and in vitro diagnostics under the MDR and IVDR regulations. The session was led by Stefan Bolleininger, Head of Consultys Medical and senior regulatory affairs consultant, who discussed key aspects of the EU regulatory system, including device classification, conformity assessment procedures, CE marking requirements, and the role of notified bodies. The webinar highlighted the importance of integrating regulatory planning early in the development process for innovation projects transitioning from research to market.

The BioPhot Platform brings together a national consortium of research institutions and universities to develop interdisciplinary research and innovation in biomedicine, medical technologies, photonics, and smart materials.
Period6 Mar 2026
Event typeWebinar
Degree of RecognitionNational