Medical Device Postmarketing Vigilance Reporting: Update and Expectations for Manufacturers - Webinar By GlobalCompliancePanel

12 June 2012, Wilmington,DE, United States

Introduction

Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008. Providing more guidance than the previous version, the new document includes new reporting terminology and concepts such as "periodic summary reporting" and "trend reporting."