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
What's inside?
- Definition and scope of PMS under IVDR
- Key PMS system components and documentation
- PMPF requirements
- Guidance on PMS reporting and periodic updates
- How to apply PMS to legacy devices
Who should read this?
- Regulatory affairs managers ensuring device compliance with IVDR
- Quality managers maintaining QMS and technical documentation
- IVD manufacturers developing PMS and PMPF plans
- Medical device consultants advising on EU regulatory frameworks
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