About this Whitepaper
A major transformation is underway for medical device manufacturers and stakeholders across the EU. The EU MDR (2017/745) and IVDR (2017/746) regulations have redefined Post-Market Surveillance (PMS), making it a central pillar of compliance, product safety, and market reputation.
What’s changing?
- PMS is now a proactive, continuous process—no longer a one-off regulatory task.
- All manufacturers must implement a documented PMS system that collects, analyses, and acts on real-world data.
- PMS must be fully integrated with risk management, clinical/performance evaluation, and CAPA processes.
- Reporting requirements are stricter: PMS Reports and PSURs must be prepared and updated according to device classification and regulatory timelines.
- Digital tools, traceability, and dedicated PMS roles are now best practice, not optional.
Why it matters for your business
This new PMS framework means compliance is more demanding, but also more valuable. Businesses must:
- Monitor and respond to user feedback, complaints, and market trends in real time.
- Ensure all PMS findings feed into risk management and product improvement.
- Maintain robust documentation and be audit-ready at all times.
- Measure PMS effectiveness with clear KPIs and continuous improvement cycles.
The MDR/IVDR PMS requirements are closely linked to quality management and regulatory audits, raising the bar for operational excellence and market access.
Take action now
The new PMS standards are already in force. Medtech and diagnostics companies must review their PMS systems, update procedures, and train staff to meet these obligations—and turn compliance into a competitive advantage.
👉 Our full white paper provides practical steps and checklists to help you build a compliant, efficient PMS system.
Download the White Paper below
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