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Clinical Evaluation Under MDR and IVDR: Practical Updates and Implementation Strategies for Medical Writers
Clinical Evaluation Under MDR and IVDR: Practical Updates and Implementation Strategies for Medical Writers
Hatem Rabeh, MD, MSc
The recent updates to the MDR and IVDR frameworks have introduced important changes that directly impact how clinical evidence is planned, documented, and reviewed. For medical writers and regulatory professionals, translating these regulatory updates into operational workflows remains challenging.
This webinar will provide a practical overview of the latest regulatory updates affecting clinical evaluation and performance evaluation. It will focus on how these changes influence clinical evaluation plans, clinical evaluation reports, post market clinical follow up activities, and evidence lifecycle management.
Through real case examples and field experience, participants will learn how to adapt documentation strategies, align evidence generation with regulatory expectations, and avoid common compliance pitfalls. The session is designed to support professionals involved in regulatory writing, clinical documentation, and evidence planning for medical devices and IVDs under the European regulatory framework.
Key takeaways for participants
- Understand the main MDR and IVDR updates impacting clinical and performance evaluation activities
- Learn how to translate regulatory requirements into practical documentation workflows
- Identify frequent compliance gaps observed during Notified Body reviews and how to prevent them
Level: Intermediate/Advanced
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