Medical device manufacturers selling in Europe are legally obligated to report adverse events, incidents, and recalls, also known as vigilance reporting. Yet European authorities suspect that underreporting is a widespread issue.
Vigilance reporting is confusing for many manufacturers active in European markets but it is critical to comply with vigilance requirements. In this whitepaper, we'll answer your biggest questions about vigilance reporting, including:
- Common triggers of medical device vigilance reports
- What needs to be reported
- What doesn’t need to be reported
- Reporting deadlines
- General guidance for reporting
You'll learn all this and more in this 7-page white paper.
About the Author:
Evangeline Loh, Ph.D., RAC (US/EU): Evangeline is Vice President of Global Regulatory Affairs at Emergo. Evangeline’s areas of expertise include European CE Marking, clinical evaluation reports, vigilance, and device classification in markets worldwide. She previously worked for Cook Medical and holds a Ph.D. in pharmacology from The University of Texas Health Sciences Center at San Antonio.