In this whitepaper you’ll find

• 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 the timelines for event reporting
• The clear distinction between reportable events during clinical investigations and vigilance reporting

Why download it

• Understand the specific requirements for SAE reporting in clinical investigations in Germany
• Plan your clinical studies with regulatory and Ethics Committee requirements in mind
• Optimise the process for tracking and reporting SAEs, in line with international standards