Post-Market Surveillance (PMS) as an interface to clinical evaluation

In this blog post, you'll learn which mandatory components an effective post-market surveillance (PMS) system must contain under the MDR, how to develop a targeted PMS plan and correctly use PMS reports or PSURs, which data sources (reactive and proactive) you should systematically evaluate, and how to practically assess identified signals and convert them into evidence. You'll also learn how PMS results can be seamlessly integrated into risk management, clinical evaluation reports (CERs), and PMCF measures.

Abbreviations

CEP	Clinical evaluation plan
CERIUM	Clinical Evaluation Report
MDR	Medical Device Regulation (EU Ordinance 2017/745)
Pmcf	Post-Market Clinical Follow-up
Pms	Post-Market Surveillance

Underlying regulations and norms

EU Regulation 2017/745 (MDR)

MDCG 2022-21

1 Introduction

Post-market surveillance (PMS) is no longer a downstream regulatory step. PMS is central to transforming real-world usage data into robust clinical evidence. In light of the MDR, PMS is mandatory, systematic, reactive, and proactive: It provides the practical experience that proves whether the assumptions and claims in your Clinical Evaluation Report (CER) remain valid or need to be adjusted. The interface between PMS and clinical evaluation is therefore not an optional feature, but the crucial control tool for benefit-risk analyses, IFU/label changes, PMCF measures, and regulatory decisions.

In daily practice, we often see PMS data collected in isolation, stored in vigilance databases, service logs, or customer feedback systems, and only fed back into the clinical assessment when problems arise. This reactive approach is risky: It slows down necessary corrections, weakens the traceability of claims, and increases the likelihood of audit findings.

The aim of this article is therefore to provide the common thread on how to set up PMS as a continuous, traceable feedback loop: from planning through collection and analysis to systematic integration into CER, risk management and PMCF.

2. Core requirements of the MDR

The MDR elevates post-market surveillance (PMS) to the status of a mandatory, systematic, and proactive core task. PMS is not an afterthought, but rather the continuous tool manufacturers use to demonstrate and manage the actual safety and performance of their products in the field.

Article 61 paragraph 11 of the MDR is a clear, practical mandate for manufacturers:

(11) The clinical evaluation and the accompanying documentation shall be updated throughout the life cycle of the device in the light of the clinical data resulting from the implementation of the manufacturer's post-market clinical follow-up plan in accordance with Part B of Annex XIV and the post-market surveillance plan in accordance with Article 84.

 For Class III and implantable devices, the post-market clinical follow-up assessment report and, where appropriate, the summary report on safety and clinical performance referred to in Article 32 be updated at least once a year on the basis of those data.

The central starting point is a documented PMS plan for each product. This plan must be risk-based and product-specific, taking into account the product class, intended purpose, the environment of use (e.g., hospital, outpatient care, home use), and market characteristics. The PMS plan specifies which data sources are systematically monitored (e.g., vigilance reports, complaints, service and maintenance data, social media monitoring, PMCF results), who bears which responsibilities, which analysis methods are applied, and which trigger criteria trigger actions (e.g., thresholds, repeated incidents, increased incidences).

Regarding reporting obligations, the MDR differentiates between device groups:

For Class I devices, a PMS report be maintained and updated as needed. In practice, it has proven useful to review this report regularly (e.g., at predefined intervals, approximately every 3–5 years) and to make ad hoc changes to relevant signals.

For Class IIa, IIb, and III, the central formatting tool is the Periodic Safety Update Report (PSUR) . The MDR sets out clearer guidelines for PSURs: Class IIa at least every two years, Class IIb and III annually.

A PSUR is more than just a list: it must include a summary benefit-risk assessment, vigilance and trend data, PMCF results, sales/utilisation figures, CAPA measures and their effectiveness, and a conclusion on newly emerged risks or changed benefit-risks.

The key point is that PMS cannot be operated in isolation. The results from PMS monitoring must be directly incorporated into risk management (ISO 14971): Residual risks must be updated, risk controls reviewed, and expanded if necessary. PMS results must also provide direct input for the Clinical Evaluation Report (CER). Data and results that raise uncertainties regarding the efficacy or safety of a claim must be used as triggers for PMCF measures and processed in the benefit-risk analysis.

In short: PMS is the continuous feedback loop that generates real evidence and thus keeps your technical documentation, claims and clinical evaluation up-to-date, robust and audit-ready.

3. Reactive vs. Proactive — both sides of the PMS coin

An effective PMS strategy combines reactive and proactive activities into a closed-loop monitoring system: Reactive measures show what has already gone wrong or changed, including vigilance alerts, customer complaints, service and maintenance reports, field safety corrective actions, as well as media observations or reports of incidents involving competing products.

In contrast, proactive activities aim to generate evidence before problems escalate: Market analyses, targeted simulations and in-house tests (e.g., stress or retrieval studies), device data analyses, and continuous monitoring of SOUP components provide insights into actual performance and potential failure modes in real-world application environments. Proactive measures allow for the systematic testing of hypotheses arising from reactive signals and the generation of robust real-world evidence, which then leads to benefit-risk reassessments and CER updates.

The strength of a PMS system lies in the interconnectedness of both sides: Reactive data acts as early warning signals, while proactive activities verify root causes and evaluate countermeasures. Only through this combined approach can trends be identified early, reliable conclusions drawn, and well-founded, documented decisions made (e.g., IFU adjustments, CAPA, design changes, or PMCF initiation).

4. PMS as a direct interface to the CER — how the integration works

Post-market surveillance provides the real data with which evidence for clinical safety claims is updated in the CER. What is crucial here is not the sporadic "finding," but the structured, statistically meaningful documentation in the PMS report/PSUR: only then can reliable incidence rates be derived, temporal trends identified, and informed decisions made for benefit-risk reassessment.

Claims regarding clinical safety must be quantitatively substantiated with measurable data (e.g., incidence rates, severity levels, time periods). In practice, this means: The PMS report/PSUR should contain structured tables and analyses. Trends are not only presented descriptively, but also, for example, with appropriate trend tests or comparative analyses. This structured documentation forms the basis for integration into the CER: the rates and analyses presented in the PMS report/PSUR are incorporated into the benefit-risk matrix, claims are reviewed (confirmed, qualified, or withdrawn), and, if necessary, PMCF studies are initiated to gather targeted evidence. Predefined analysis methods in the PMS plan are crucial (e.g., relative increase in incidence > X%, statistically significant deviation).

Update of the clinical evaluation and benefit-risk reassessment: Relevant PMS signals (e.g., increased complication rates, recurring operator errors, new serious events) trigger a formal reassessment of the risks.

Identification of new risk types: PMS not only reveals changes in the frequency of known risks, but can also reveal entirely new hazards—such as material failures in certain batches, interference with third-party devices, software vulnerabilities, or application-specific risks for specific user groups. Such observations require a plausibility and root cause analysis and, if necessary, the inclusion of the new risk in the risk analysis (ISO 14971).

In short: PMS evidence for clinical safety claims is created through structured data collection and standardized, transparent analysis in the PMS report/PSUR—especially the calculation and interpretation of [number of points]. Only in this way can claims be robust, benefit-risk reassessments be traceable, and CER updates be audit-proof.

5. The operational PMS cycle — put into practice

The operational PMS cycle is not a theoretical diagram, but the practical framework used to translate real data into effective regulatory and clinical measures. To operate PMS as a living, audit-proof process rather than a silo, a clearly structured cycle is recommended.

In the "Plan " step, you create a product- and risk-based PMS plan. This plan defines objectives, data sources, signal detection criteria, responsibilities, analysis methods, and reporting cycles (PMS report, PSUR).

The Collect step ensures clean raw data. Collect both reactive (vigilance alerts, customer complaints, service/maintenance reports, FSCA data) and proactive data (in-house tests, market analyses).

In the Analyze section, you transform data into insights: perform trend analysis, cluster detection, and signal scoring (e.g., frequency × severity × plausibility). Every potentially relevant signal is documented.

The report step formalizes the results: Create or update the PMS report or PSUR according to MDR requirements – the structure and content depth specified in the MDCG Guidance 2022-21 is recommended. Use templates that contain a clear executive summary with a concise benefit-risk conclusion and define whether the benefit-risk balance is unchanged, improved, or worsened. The core part of the report should systematically map out the scope and sources of data collection (including basic UDI-DI and scope/"leading device" for device groupings), the reporting period, sales and usage figures, and the observed events with the calculation of incidence rates and, where appropriate, confidence intervals or other statistical indicators. Furthermore, vigilance and trend analyses, a summary of the PMCF results, CAPA summaries, and, if applicable, information on comparable devices should be included in the PSUR.

Act & Update step involves concrete measures: Initiate CAPA processes, IFU/label revisions, firmware patches, or user training. At the same time, update the risk management documents (ISO 14971) and the CER, documented with version numbers. Regular reviews of the PMS plan (e.g., after a PSUR release or in the event of design changes) are also important.

In conclusion, the operational PMS cycle is a dynamic, iterative process. Defined roles, standardized templates, and consistent traceability transform raw reports into robust clinical evidence and ensure that CER, IFU, and risk management documents always reflect the current real-world findings.

6. Common mistakes (and how to avoid them)

A common misconception is that PMS is simply about handling complaints. A PMS that only handles complaints is reactive and doesn't generate reliable real-world evidence. This can be avoided by demonstrating proactive activities: in-house testing, targeted market analyses, and analyses of similar products. Define in your PMS plan which proactive data sources you regularly query and document these activities in a report.

Another common mistake is confusing the PMS report (Class I) and the PSUR (Class IIa–III), or using the wrong reporting interval. The assignment must be clear: PMS report for Class I with needs-based updates, PSUR for IIa–III with cycles established by the PMS plan (e.g., IIa ≥ every 2 years, IIb/III often annually).

Very often, PMS results are not integrated into the other regulatory documents. PMS findings must not remain in a data silo; they must be incorporated into risk management documents (ISO 14971), the CER, and the IFU/label.

Outdated documentation is another common problem. Therefore, establish clear update cycles and documented justifications: annual mandatory updates for Class III/implantable devices, risk-based reviews for other classes, and ad hoc revisions for defined triggers (e.g., statistically significant deviations, clusters, new serious events). Each revision must be versioned, documented with the trigger, and released to prevent old claims or IFU versions from remaining in the field.

Weak trend analyses lead to reportable trends (Article 88 MDR) being overlooked. Implement methodical procedures for trend and cluster detection: calculate incidence rates with confidence intervals and use simple signaling scores with documented thresholds. Furthermore, document the statistical methods used and the decision boundaries in the PMS plan.

In summary: avoid isolated solutions, unclear reporting rules, weak methodology, and a lack of traceability by implementing proactive PMS activities, clearly defining reporting types and cycles, systematically linking PMS results with CER/risk management/IFU, introducing regular and trigger-based update processes, and implementing robust trend detection procedures.

7. Conclusion

Post-market surveillance is not a tedious chore, but the central control tool for transforming real-world usage data into robust clinical evidence. Only a well-defined, risk-based PMS plan that combines reactive reporting systems with proactive measures provides the signals that keep your benefit-risk analysis, claims, and IFU texts up-to-date. Avoid typical errors, isolated solutions, and poor data quality through structured templates, mandatory fields, and regular reviews. When PMS is established as a continuous cycle (Plan → Collect → Analyze → Report → Act & Update) and anchored both technically and organizationally, it becomes the driving force for patient safety, product quality, and regulatory robustness.

8. How we can help you

We provide pragmatic support throughout the entire PMS cycle—Plan → Collect → Analyze → Report → Act & Update—and ensure that your post-market surveillance truly serves as a robust interface to clinical evaluation. Concise and practical: we develop the PMS plan, implement structured data collection, conduct trend analyses and PSUR drafts according to MDCG specifications, and support CAPA, PMCF, and CER/IFU updates through to efficacy testing.

If you wish, we can start with a comprehensive gap analysis of your current PMS landscape and provide concrete, prioritized actions—making PMS not just a compliance task, but your tool for robust, ongoing clinical evidence.

Want to know more? Contact us for a free initial consultation!

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