Framework
EUIVDR — PMS and Vigilance
The EU IVDR 2017/746 establishes a comprehensive post-market surveillance (PMS) and vigilance system requiring IVD device manufacturers to proactively monitor device performance, collect and analyze field data, and report serious incidents and field safety corrective actions. These obligations are continuous throughout the device lifecycle and integrate with post-market performance follow-up activities.
Overview
Background
Under Regulation (EU) 2017/746, the EU significantly strengthened PMS and vigilance requirements for IVD devices compared to the previous IVD Directive. The regulation introduced structured PMS plans, periodic safety update reports (PSURs), and enhanced vigilance reporting timelines, recognizing the critical role of IVD devices in clinical decision-making and the potential downstream impact of IVD performance issues on patient outcomes.
Applicability
These requirements apply to all manufacturers of IVD medical devices placed on the EU market. Class C and D device manufacturers must prepare periodic safety update reports (PSURs), while all classes require PMS plans. Vigilance obligations include reporting serious incidents within defined timelines and implementing field safety corrective actions. Authorized representatives, importers, and distributors also have reporting obligations.