A webinar on the European Union framework for medical devices and in vitro diagnostics introduced participants to the significant changes within the MDR and IVDR.
Given that regulatory requirements have changed significantly in recent years, particular attention has been paid to the importance of early understanding for innovation projects moving from the research environment to the market.
The webinar was moderated by Stefan Bolleininger, CEO of Consultys Medical and Senior Regulatory Affairs Consultant, who specialises in supporting early-stage innovation projects and helping to navigate the EU regulatory environment when preparing products for CE marking.
The webinar covered:
- EU regulatory framework for MDR and IVDR, role of notified bodies and CE marking requirements
- Classification of medical devices and IVDs and its role in the choice of regulatory pathway
- Conformity assessment procedures and required documentation
- Harmonised standards, common specifications and guidelines
- Integrating regulatory planning at an early stage
