Your 5 minute Post-Market Survelliance (PMS) Checklist

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Medical devices – the path to CE marking and market
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Medical devices – the path to CE marking and market
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Achieving a CE mark is a major milestone—but it is not the end of the regulatory journey.  Once a medical device enters the market, Post-Market Surveillance (PMS) becomes the  primary mechanism for demonstrating that the device remains safe, effective, and  compliant throughout its lifecycle. 

A well-structured PMS system ensures audit readiness, supports continuous improvement,  and helps manufacturers identify and mitigate risks based on real-world use. 

This checklist provides a practical overview of key PMS requirements under EU MDR.

1.Embed PMS Into Your Quality Management System  (QMS) 

PMS should function as an active and continuous process within the Quality Management  System, not as a standalone activity. 

Manufacturers should: 

  • Systematically collect complaints, feedback, and vigilance data 
  • Analyse trends and signals on an ongoing basis 
  • Ensure PMS outputs feed into risk management and clinical evaluation 

Embedding PMS into the QMS supports regulatory compliance and audit transparency.

2. Create a Device-Specific PMS Plan 

Each device must have a documented, device-specific PMS Plan that defines:

  • The type of data collected 
  • Data sources and review frequency 
  • Roles and responsibilities 
  • Methods for analysing and escalating findings 

ISO/TR 20416:2020 provides a widely accepted structure for developing PMS plans aligned  with EU MDR expectations.

3.Prepare the Required PMS Reports 

EU MDR reporting requirements depend on the risk class of the device:

  • Class I: Maintain a PMS Report 
  • Class IIa, IIb, III: Maintain a Periodic Safety Update Report (PSUR) 

PSURs must include: 

  • Benefit–risk evaluation 
  • PMCF outcomes 
  • Sales volume and population exposure 
  • Summary of corrective and preventive actions 

Reports must be kept up to date and available for review by notified bodies and competent  authorities.

4.Plan and Maintain PMCF Activities 

A Post-Market Clinical Follow-up (PMCF) Plan is required even when new clinical studies  are not conducted. 

PMCF activities may include: 

  • User surveys and registries 
  • Literature reviews 
  • Real-world performance analysis

MDCG 2020-7 provides guidance on structuring PMCF activities to confirm safety,  performance, and benefit-risk balance over time.

5.Close the PMS Feedback Loop 

Effective PMS requires action—not just data collection. 

Manufacturers should: 

  • Update the Risk Management File 
  • Revise the Clinical Evaluation Report (CER) 
  • Review IFUs and labelling where necessary 
  • Document decisions, including justification when no changes are required 

Closing the feedback loop demonstrates regulatory maturity and continuous improvement. PMS as an Ongoing Health Check 

Post-Market Surveillance is not only a compliance requirement—it is a mechanism for  learning from real-world use, improving patient safety, and maintaining long-term trust with  regulators, healthcare professionals, and patients. 

A well-maintained PMS system ensures readiness for audits, inspections, and evolving  regulatory expectations. 

FAQs

1What is Post-Market Surveillance (PMS)?
Post-Market Surveillance is a continuous process of collecting and analysing data after a device is placed on the market to ensure ongoing safety and performance.
2Is PMS mandatory under EU MDR?
Yes. PMS is mandatory for all medical devices under EU MDR and must be documented, maintained, and reviewed regularly.
3What is the difference between PMS Report and PSUR?
A PMS Report applies to Class I devices, while PSURs are required for Class IIa, IIb, and III devices and include more detailed safety and performance data.
4Is a PMCF plan required for all medical devices?
Not necessarily. Under the EU MDR, a PMCF plan is expected for most devices as part of the post-market surveillance system. However, PMCF activities may be reduced or not required for certain devices where sufficient clinical evidence and long-term safety and performance are already well established. In such cases, the manufacturer must provide a clear, well-documented justification explaining why PMCF activities are not necessary. This justification should be included within the PMCF plan or referenced in the Clinical Evaluation Report (CER) and be supported by robust clinical data.
5How often should PMS activities be reviewed?
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Quality Management System

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