EU Medical Device Vigilance Reporting

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.