How to Create a Post-Market Surveillance (PMS) Plan Under MDR

Under MDR, a Post-Market Surveillance (PMS) plan is not optional — it’s mandatory. This guide explains how to design a PMS plan that meets EU requirements and ensures your devices remain safe and effective throughout their lifecycle.

What is a PMS Plan?

A Post-Market Surveillance (PMS) plan is a documented process for collecting, analyzing, and acting on data about a medical device after it has been placed on the market. It ensures that companies monitor device performance continuously and take corrective actions when necessary.

Why is a PMS Plan Important?

  • Regulatory Requirement: MDR (EU 2017/745) makes PMS mandatory for all medical devices.
  • Patient Safety: Helps identify risks that may not have appeared during pre-market testing.
  • Market Access: Without PMS, companies risk losing CE certification.
  • Continuous Improvement: Data collected can guide product enhancements.

Key Components of a PMS Plan

1. Data Collection Methods

  • Customer feedback & complaints
  • Clinical studies & scientific literature
  • Sales and distribution data
  • Post-Market Clinical Follow-Up (PMCF) studies

2. Evaluation Process

  • Define how data will be analyzed.
  • Use statistical methods to detect trends or anomalies.
  • Link findings to risk management and CAPA processes.

3. Responsibilities and Roles

  • Assign a compliance officer or team.
  • Ensure cross-department collaboration (regulatory, quality, clinical).

4. Reporting and Documentation

  • Periodic Safety Update Report (PSUR) for Class IIa, IIb, and III devices.
  • Vigilance reporting for serious incidents.
  • Keep all findings audit-ready.

5. Integration with QMS

  • Ensure the PMS plan is embedded within your Quality Management System (ISO 13485).
  • Findings should lead to continuous improvement actions.

Step-by-Step Process to Create a PMS Plan

  1. Define objectives and scope of the plan.
  2. Select data sources and collection methods.
  3. Set evaluation criteria and risk thresholds.
  4. Assign responsibilities across departments.
  5. Document reporting timelines and escalation procedures.
  6. Review and update the PMS plan regularly.

Common Mistakes to Avoid

  • Treating PMS as a one-time task instead of ongoing monitoring.
  • Collecting data but failing to analyze it.
  • Poor integration between PMS, risk management, and CAPA.
  • Not training employees on their role in PMS activities.

Conclusion

Creating a strong PMS plan under MDR may take effort, but it’s essential for compliance, patient safety, and long-term business success.

By setting up clear processes, documenting thoroughly, and integrating PMS with your QMS, medical device companies can ensure not just compliance — but also improved trust, safety, and competitiveness in the global market.