SAE Reporting in Germany: A Guide for Clinical Investigations under MDR 2017/745
🔍 In this whitepaper, you’ll find detailed insights on:
- The requirements for reporting Serious Adverse Events (SAE) in clinical investigations under Articles 62 and 74.2 of the MDR in Germany
- Investigator and sponsor responsibilities, including timelines for event reporting
- The clear distinction between reportable events during clinical investigations and vigilance reporting
💡 Why download our whitepaper?
- Understand the specific requirements for SAE reporting in clinical investigations in Germany
- Learn how to effectively plan your clinical studies, taking into account regulatory and Ethics Committee requirements
- Discover strategies to optimize the process for tracking and reporting SAEs, in compliance with international standards
Don’t miss this essential resource for ensuring the safety of medical devices during clinical studies! Click the link below to download and stay compliant with the latest regulatory requirements.
