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PMS Plan

  • Maria
  • 11 hours ago
  • 3 min read

How to Build a MDR-Compliant PMS Plan: A Guide for Medical Device Manufacturers

The EU MDR 2017/745 has transformed how manufacturers monitor the safety and performance of medical devices after CE marking. At the core of this shift is the Post-Market Surveillance (PMS) Plan—a mandatory document for all classes of devices, from Class I to Class III.

But what exactly is required in a PMS Plan? How do you ensure it’s compliant with Annex III of the MDR and integrated with your overall quality and regulatory system?

In this blog, we walk you through the essentials of a PMS Plan: what it is, what to include, and how to align it with the rest of your technical documentation.


What is a PMS Plan?

A Post-Market Surveillance Plan outlines how a manufacturer will proactively monitor and evaluate the performance of a medical device once it is on the market. It is not just a document—it is a living system of processes and responsibilities designed to detect problems early, protect users, and ensure compliance.

According to Annex III of MDR, the PMS Plan must be proportionate to the risk class of the device and must enable manufacturers to continuously update the benefit-risk assessment, clinical evaluation, and risk management documentation.


Who Needs a PMS Plan?

All manufacturers of CE-marked devices under MDR must have a PMS Plan.

This includes:

  • Class I devices (even if they do not require Notified Body involvement)

  • Class IIa, IIb, and III devices

  • Custom-made devices

  • Legacy devices under Article 120(3) (if still marketed)

The depth and frequency of activities may vary depending on the risk class, device type, patient population, and regulatory status—but the requirement for a PMS Plan is universal.


What Should a PMS Plan Include?

Under Annex III, Section 1.1 of MDR, a PMS Plan must include:

  1. A proactive and systematic process to collect and analyze post-market data

  2. Methods and frequency for data collection, including:

    • Feedback from users

    • Incident reports

    • Complaint handling

    • Registry or literature data

    • PMCF activities (if applicable)

  3. Indicators and thresholds for detecting trends

  4. Effective tools for signal detection, data analysis, and reporting

  5. Corrective and preventive action (CAPA) mechanisms

  6. Integration with risk management and clinical evaluation updates

  7. Responsibilities and resources involved in PMS activities

  8. Reference to PMS Report or PSUR, depending on the risk class

The PMS Plan should be device-specific or apply to homogeneous device families with similar risk and usage profiles.


PMS Plan vs. PMS Report vs. PSUR: What’s the Difference?

  • PMS Plan: The forward-looking strategy and process definition (Annex III, 1.1)

  • PMS Report: Required for Class I devices, summarizing findings and conclusions from PMS activities (Article 85)

  • PSUR (Periodic Safety Update Report): Required for Class IIa, IIb, and III, includes PMS findings, benefit-risk analysis, and PMCF results (Article 86)

Each of these documents is interrelated and must be updated regularly. The PMS Plan should clearly state how these outputs are generated and maintained.


Tips for an Effective PMS Plan

To create a compliant and useful PMS Plan:

  • Use real data sources: Sales, complaints, trend reports, clinical registries

  • Define measurable indicators: Time to resolution, incident rates, alert thresholds

  • Align with QMS procedures: Especially CAPA, complaint handling, and vigilance

  • Involve the right team: Quality, Regulatory, Clinical, and Customer Support

  • Plan updates: Define when and how the PMS Plan will be reviewed and revised

For Notified Body-reviewed devices, make sure your PMS Plan is consistent with the Clinical Evaluation Plan, Risk Management File, and PMCF Plan.


Common PMS Plan Gaps to Avoid

Regulators and Notified Bodies often identify these issues:

  • Vague or copy-pasted text from ISO 13485

  • Lack of connection to real-world data sources

  • Missing feedback loops between PMS and CER/RMF

  • Undefined responsibilities for PMS execution

  • No justification for omitted PMS activities

A good PMS Plan is tailored, justified, and traceable—not generic.


How AF Pharma Can Help

At AF Pharma, we work with manufacturers worldwide to develop and maintain fully compliant PMS Plans tailored to their devices, markets, and internal systems. Our services include:

  • Creation of PMS Plans aligned with MDR Annex III

  • Integration with CER, PMCF, and RMF documentation

  • PMS strategies for legacy and high-risk devices

  • Custom PMS procedures and forms for ISO 13485 and MDSAP systems

  • Audit support and documentation updates after Notified Body feedback


Need a MDR-compliant PMS Plan or want to review your current one?Get in touch with our regulatory team at: www.afpharmaservice.com or email maria@afpharmaservice.com



PMS plan template

 
 
 

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