PMS requirements under IVDR

The post-market surveillance (PMS) system is a critical requirement under the EU In Vitro Diagnostic Medical Device Regulation (IVDR) (2017/746). This comprehensive white paper explores the latest PMS obligations for IVD manufacturers, ensuring compliance with the stringent IVDR requirements.

Why read this white paper?

• Clarify PMS definitions and scope: understand the distinction between PMS and market surveillance, and learn how PMS integrates with quality management systems (QMS)
• Detailed breakdown of PMS plans and reports: explore essential documents like the PMS Plan (PMSP), PMS Report (PMSR), and Periodic Safety Update Report (PSUR), with practical guidelines
• Manage legacy devices effectively: understand PMS requirements for legacy devices and devices placed on the market before May 26, 2022
• Post-market performance follow-up (PMPF): learn how to update performance evaluations and continuously improve device safety and performance
• Compliance with standards and guidelines: explore key references, including ISO 13485, ISO 14971, MDCG guidance and other regulatory resources