Skip to main content

Developing and marketing IVDs and CDx in Europe: Challenges and lessons learned

This webinar will provide insights into the regulatory framework and challenges for the development and marketing of in vitro diagnostics (IVDs) and companion diagnostics (CDx) in Europe, covering regulatory strategy, critical timelines and interactions with stakeholders. The speakers will share lessons learned on the basis of case studies and will present the latest policy and regulatory framework for IVDs and CDx and provide an update on recent digital health initiatives in Europe.

The webinar will cover the following points:
• Regulatory framework for IVDs and CDx in the EU, the UK and Switzerland
• Development in accordance with regulatory strategy
• IVD and CDx conformity assessment
• Update on the latest policy developments for IVDs and CDx, including digital health