Under the EU Medical Device Regulation (EU MDR 2017/745), every manufacturer placing a medical device on the EU market must implement a comprehensive post-market surveillance (PMS) system.

This system also includes PMCF (Post-Market Clinical Follow-up) and PSUR (Periodic Safety Update Report) — three interconnected processes that ensure continuous safety monitoring and compliance throughout the entire lifecycle of a medical device.

This article explains:

• the purpose of PMS, PMCF and PSUR,

• how these components work together,

• why they are essential for manufacturers,

• and provides example documents developed for an illustrative product.

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1. What is PMS and why is it needed?

Post-Market Surveillance (PMS) is a structured system for collecting, monitoring and analysing safety and performance data after a device is placed on the market.

PMS helps manufacturers to:

✔ Detect potential risks early

For example: an increase in complaints for a specific lot may indicate manufacturing deviations.

✔ Monitor real-world performance

Devices can behave differently in clinical or home-use environments compared to controlled testing.

✔ Improve IFU and safety information

Recurring user confusion often points to unclear instructions.

✔ Maintain up-to-date technical documentation (CER, RMF)

PMS is a primary source of input for clinical evaluation and risk management updates.

👉 PMS is mandatory for all device classes (I, IIa, IIb, III).

Only the depth and frequency of reporting differ.

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2. What is PMCF and when is it required?

Post-Market Clinical Follow-up (PMCF) is an extension of clinical evaluation, designed to confirm the long-term safety and performance of a device.

PMCF activities may include:

• systematic literature review,

• analysis of adverse events,

• user or clinic surveys,

• comparison with other devices,

• observational studies,

• assessment of usage trends.

PMCF is needed when:

• there are gaps or uncertainties in clinical data,

• the technology or material is new,

• the Notified Body requires additional confirmation,

• the intended purpose or clinical techniques evolve,

• the device belongs to a medium- or high-risk category.

👉 PMCF is not always a clinical trial — it is a flexible tool tailored to the device’s risk profile.

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3. What is PSUR and who must submit it?

Periodic Safety Update Report (PSUR) is a structured summary of PMS and PMCF results covering a defined period.

Who must submit PSUR?

PSUR typically includes:

• sales volumes and geographical distribution,

• adverse event analysis and trend evaluation,

• PMCF data summary,

• benefit–risk assessment,

• CAPA and RMF updates,

• manufacturer’s conclusion on ongoing MDR compliance.

PSUR is one of the key documents reviewed by Notified Bodies.

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4. How PMS, PMCF and PSUR work together

These three elements form a continuous MDR lifecycle loop:

1. PMS Plan — defines data sources and monitoring methods

2. PMS Data Collection — complaints, trend monitoring, literature

3. PMCF Plan — if additional clinical validation is needed

4. PMCF Evaluation Report

5. PSUR / PMS Report — formal periodic reporting

6. CER and RMF updates

7. CAPA implementation, if required

8. Start of the next cycle

This cycle ensures continuous safety oversight and regulatory compliance.

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5. Example documents (prepared for an illustrative device)

To demonstrate practical MDR documentation structure, we prepared two example files based on an illustrative medical device.

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📄 Example: PMS/PMCF Plan

This document demonstrates:

• the structure of a PMS plan,

• trend analysis criteria,

• PMCF activity design,

• linkage with Risk Management.

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📄 Example: PSUR

This report includes:

• Executive Summary,

• sales and AE-rate analysis,

• PMS and PMCF findings,

• graphical trend analysis,

• risk–benefit matrix,

• CAPA and RMF updates.

These samples illustrate typical MDR documentation and are applicable across device classes.

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6. Conclusion

PMS, PMCF and PSUR are essential MDR mechanisms that enable manufacturers to:

• identify risks early,

• ensure stable device performance,

• maintain up-to-date technical documentation,

• respond effectively to real-world usage trends,

• demonstrate ongoing compliance to Notified Bodies.

Regardless of device class, a robust PMS system strengthens product quality and market trust.

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What we offer to manufacturers and importers

We support companies with comprehensive MDR documentation services:

• PMS Plan / PMS Report

• PMCF Plan / PMCF Evaluation Report

• PSUR (Class IIa / IIb / III)

• Clinical Evaluation Report (CER) updates

• Risk Management File (ISO 14971) preparation

• Documentation audit for NB inspections

• Full MDR Technical Documentation preparation

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Contact us

For support with PMS, PMCF or PSUR preparation, you can reach us via the contact form on our website or by email:

📩 s.kharchenko@yahoo.com

We will get back to you shortly with the best cooperation options.