Inside the IVDR performance study review: competent authority insights and practical guidance

About this session

- Tracing the evolution of IVDR governance and how MDCG working groups shaped today’s framework and merged responsibilities over recent years
- Exploring behind the scenes of performance study assessments, including what is discussed within the competent authority review process and how applications are evaluated
- Sharing practical recommendations, common pitfalls, lessons learned, and strategies for preparing approval-ready submissions

Speaker

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  Nebojsa Serafimovic

  Assessor Medical Devices, Senior Expert · Austrian Agency for Health and Food Safety

  Speaker