Join us for a webinar on the European Union framework for medical devices and in vitro diagnostics. The requirements for MDR and IVDR have changed significantly in recent years and an early understanding of the regulatory conditions is crucial for innovation projects moving from the research environment to the market.
The webinar will take place on 6 March at 10.00.
The webinar will be moderated by Stefan Bolleininger, CEO of Consultys Medical and Senior Regulatory Advisor, who specialises in supporting early stage innovation projects and helping to navigate the EU regulatory environment when preparing products for CE marking.
Topics covered in the webinar:
- 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
Norise: Zoom platform
Working language: english
Registration: https://luma.com/48rvig6y
Participants are invited to send their questions by 9 February by e-mail: alise.ose@osi.lv
Please note that the webinar will be recorded.