Post-market surveillance under MDR

PMS as part of the quality system

PMS does not stand alone but is closely linked to other parts of the quality system. The information collected through PMS serves as input for, among others, risk management, clinical evaluation, and corrective and preventive actions.

In addition, PMS is increasingly connected to other domains. Data plays a growing role, for example when personal data is processed as part of monitoring activities (see also: https://www.unitronregulatory.nl/why-the-gdpr-matters/). Continuous monitoring is also becoming more important for software and AI systems, especially in light of new regulatory developments.

A well-implemented UDI system supports these processes by improving traceability, allowing signals from the market to be more easily linked back to specific products or batches (see: https://www.unitronregulatory.nl/udi-identification-and-traceability-in-the-eu-mdr/).

The role of data within PMS

PMS uses different types of information. In practice, this usually involves a combination of:

• complaints and incident reports
• scientific literature
• user feedback and market information

The value of this data is not only in its volume, but especially in its interpretation. Without analysis, it remains information rather than insight.

For certain product characteristics, additional considerations may apply. For example, the chosen sterilization method can influence the long-term performance of a device. A similar situation applies to anti-microbial coatings, where specific risks and claims must be carefully assessed (see: https://www.unitronregulatory.nl/anti-microbial-coatings-for-medical-devices-under-mdr-2/).

Practical challenges

Although the foundation of PMS is present in many organizations, its practical implementation often falls short. This typically manifests in three recurring issues:

• data is collected but not systematically analyzed
• the link with other processes is weak or missing
• PMS plans are too generic and not sufficiently product-specific

As a result, trends remain unnoticed and the available information is not fully utilized. PMS then becomes a formal requirement rather than an active decision-making tool.

PMS throughout the product lifecycle

An important principle of PMS is that it is carried out throughout the entire lifecycle of a medical device. Risks may change over time due to variations in use, new user groups, or external factors.

This means PMS must be both reactive and proactive. The level of detail should always be proportionate to the risk class of the device. For higher-risk devices, additional obligations apply, such as the preparation of a Periodic Safety Update Report (PSUR).

From obligation to tool

While PMS is often approached as a regulatory requirement, its real value lies in supporting insight and decision-making. A well-functioning PMS system helps organizations better understand how their device performs in real-world conditions and where improvements may be needed.

In practice, this means PMS is not only about documenting information, but also about answering questions such as:

• Are the identified risks still valid?
• Do we see trends that require action?
• Should we adjust the design or intended use?

By applying PMS in this way, it becomes an active part of the quality system rather than a standalone document.

Conclusion

Setting up a PMS system is an important first step, but its effectiveness is determined by how it is used in practice. By integrating PMS into existing processes and actively using it as a source of insight, manufacturers not only ensure MDR compliance but also continuously improve their products.

If you have questions about setting up or optimizing your PMS system, feel free to get in touch for further discussion.