Framework
EUMDR — PMS and Vigilance
The EU MDR 2017/745 establishes a comprehensive post-market surveillance (PMS) and vigilance system requiring manufacturers to proactively monitor device performance, collect and analyze data from the field, and report serious incidents and field safety corrective actions. These obligations span the entire lifecycle of the device and feed into the ongoing benefit-risk assessment.
Overview
Background
Under Regulation (EU) 2017/745, the EU significantly strengthened post-market surveillance and vigilance requirements compared to the previous directives. The regulation introduced structured PMS plans, periodic safety update reports (PSURs), and enhanced vigilance reporting timelines, reflecting lessons learned from high-profile device safety incidents.
Applicability
These requirements apply to all manufacturers of medical devices placed on the EU market. Class IIa, IIb, and III 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 when necessary. Authorized representatives, importers, and distributors also have reporting obligations.