Post-market surveillance reloaded – From a static plan to a dynamic system with MDCG 2025-10

With the MDR and IVDR, post-market surveillance (PMS) became the central driver in the life cycle of medical devices. The legal direction has always been clear: proactive, systematic and throughout the life cycle. But in practice, there was often a methodological vacuum. Manufacturers and notified bodies struggled with the granularity of plans and the definition of ‘proactivity’.

With the publication of MDCG 2025-10 in December 2025, the decisive framework for interpretation is now available. The guideline transforms PMS from an administrative chore into a highly networked lifecycle system that is deeply rooted in quality management (QMS).

Integration into QMS: The end of document silos

Until now, PMS has often been viewed as an isolated collection of reports. MDCG 2025-10 radically corrects this approach: PMS is not a static document, but a continuous closed-loop system of data collection, analysis and regulatory consequences.

For audits, this means a shift in focus: it is no longer sufficient to present a PMS plan. Manufacturers must demonstrate the effectiveness of bidirectional interfaces:

• Risk management (ISO 14971): PMS data must flow directly back into the validation of risk acceptance. Every new signal in the field requires a review of the existing risk analysis.
• Clinical evaluation (CER/PER): The PMS system acts as the primary data source for continuously verifying clinical evidence and the benefit-risk ratio. The PSUR (Periodic Safety Update Report) becomes the key output document that aggregates the clinical relevance of market data.

Proactive data collection and state of the art

The often vague term ‘proactivity’ is operationalised by the guideline. While reactive data (complaints, vigilance) merely reflect the status quo, MDCG 2025-10 calls for a targeted benchmarking strategy.

Manufacturers must proactively demonstrate that their product remains safe and effective compared to the current state of the art. This requires systematic screening of specialist literature, registries, user feedback and targeted comparison with competitive data, including the use of publicly available data sources such as EUDAMED. Post-market clinical follow-up (PMCF) becomes an active tool in this process: it is not an optional add-on, but must be an integral, risk-based component of the PMS system, closing specific knowledge gaps that cannot be covered by reactive systems.

Trend reporting: statistical precision instead of gut feeling

Probably the most significant tightening concerns trend reporting in accordance with Art. 88 MDR / Art. 83 IVDR. MDCG 2025-10 requires that thresholds are not set arbitrarily, but on the basis of statistically robust methods.

• Methodology: The use of instruments such as Poisson distribution or control charts (e.g. u-charts) is becoming standard practice for objectively identifying significant increases in incidence rates.
• Data quality: The guideline warns against ‘noisy data’. Sources such as social media can be used, but must be validated for bias. Manufacturers must use methodological filtering to separate genuine user feedback from irrelevant noise before data is included in the statistical evaluation.

Custom-made devices: Methodological clarity through grouping

For manufacturers of custom-made devices, the guideline provides important clarification on how to cope with the documentation burden. Instead of forcing an isolated PMS cycle for each individual product, MDCG 2025-10 allows for group-based evaluation. Products with similar intended uses and identical design principles can be evaluated together. This increases the statistical significance of the data and ensures that a valid trend can be identified even with small quantities.

Focus of market surveillance: consistency instead of documentation

A key aspect of the new guideline is the expectations placed on regulatory authorities and notified bodies. The PMS system is now considered an indicator of a company's ‘regulatory health’. A system that fails to identify any trends or necessary adjustments to the clinical evaluation over a period of years will be considered suspicious in future. MDCG 2025-10 requires auditors to critically question the depth of data analysis: Were corrective actions (CAPA) actually triggered by PMS signals? Is there documented consistency between the field reports and the safety evidence declared in the PSUR?

Conclusion: PMS as an ‘evidence machine’

MDCG 2025-10 marks the end of the era of static reports. PMS is becoming an ‘evidence machine’ that continuously feeds data to support clinical claims and ensure competitiveness. The PMS plan is no longer a form, but the strategic roadmap for patient safety.

Quick check: Is your PMS system MDCG-compliant?

• 1. Interfaces: Do PMS, risk management and clinical evaluation demonstrably and bidirectionally interact with each other?
• 2. Data quality: Are unspecific sources methodically checked for bias (distortion) and filtered?
• 3. KPIs & statistics: Are thresholds for trend reporting quantitatively defined and statistically justified?
• 4. Response time: Does the PMS system specify the time limits within which trend alerts must be responded to (time-to-action)?
• 5. Proactivity: Is there active comparison with competitor data and the state of the art?