The European regulatory framework for medical devices and in vitro diagnostics has undergone significant changes with the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
These changes directly affect research institutions, startups, and innovation teams developing new healthcare technologies and preparing them for market entry.
Topics covered
- Structure of the EU regulatory system under the Medical Device Regulation and In Vitro Diagnostic Regulation, including the role of Notified Bodies and CE marking requirements
- Classification of medical devices and in vitro diagnostics and its impact on regulatory pathways
- Conformity assessment procedures and required technical documentation
- Harmonized standards, common specifications, and applicable guidance
- Integration of regulatory planning into early-stage product development
The webinar will be led by Stefan Bolleininger, Managing Director and Senior Regulatory Consultant at Consultys Medical, who has extensive experience supporting research institutions, startups, and innovation platforms across Europe in navigating regulatory pathways.
The webinar will be recorded.
The project Biomedical and Photonics Research Platform for the Development of Innovative Products – BioPhoT is implemented within the framework of the national research programme 'Innovation Fund – Long-Term Research Programme', funded by the Ministry of Economics. Project number: IVPP-EM-Innovation-2024/1-0002.
