Description
Date of webinar: March 2025
Understanding the regulatory requirements for In Vitro Diagnostic (IVD) devices is essential for successful market access. This webinar will explore the differences between EU IVDR and Canada’s regulatory framework, focusing on the role of Notified Bodies in the EU and Health Canada’s approval process.
EU Territory – Key Insights:
🔹 Role of Notified Bodies (NBs) within the EU regulatory system
🔹 Steps in the conformity assessment process under IVDR
🔹 Current status of IVDR implementation (EU Commission survey results)
🔹 Future outlook on EU regulations (e.g., targeted evaluation)
Canadian Territory – Key Insights:
🔹 IVD classification in Canada (Risk Classes 1-4) vs. EU IVDR Classes A-D
🔹 Licensing requirements, including MDSAP certification and technical documentation review
🔹 Health Canada’s technical documentation review process and IMDRF TOC format
🔹 Strategies for leveraging EU technical documentation for Canadian submissions (and vice versa)
🔹 Available guidance, presubmission support, review timelines, fees, and the role of the regulatory correspondent
Speakers & Moderator:
🎤 Guest Speakers:
✅ Marta Carnielli – Head of Certification IVD at TÜV SÜD
✅ Sarah Bassler – Senior Partner at PASB MedTech Solutions Inc.
🎤 Moderator:
✅ Davide Turchi – RA & PMA Senior Manager and Deputy PRRC, Regulatory Affairs at Obelis Group
