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14th Annual Outsourcing in Clinical Trials: Medical Devices Europe 2026

Panel Stream B: In Vitro Diagnostics Performance & Validation track

Coordination assessment processes for medical devices and IVDs

Tue, Jan 27, 2026 · 4:00–4:30 PM CET Holiday Inn Munich City Centre

About this session

- Discussing lessons learned from coordinated assessments for medical devices under Article 78
- Considering the impact of the European Commission’s pilot project for IVD stakeholders
- Sharing practical approaches for preparing evidence packages and coordinating with multiple authorities during assessments
Moderator: Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

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