How does the PMS plan relate to the PMPF plan?

The PMS plan covers general post-market data collection across all device classes, while the Post-Market Performance Follow-up plan is a more specific, proactive activity focused on continuously updating clinical performance evidence, particularly important for Class C and D devices. PMPF findings feed into and update the broader PMS system, but the two plans serve distinct scopes.

Does the same PMS plan structure apply regardless of device risk class?

No. The intensity and reporting cadence differ by class: Class A and B devices typically produce a PMS report at manufacturer discretion or upon request, while Class C and D devices require a Periodic Safety Update Report (PSUR) submitted at prescribed intervals, meaning the PMS plan for higher-risk devices must be structured to feed that periodic reporting cycle.

What is a common mistake manufacturers make when drafting a PMS plan?

A common mistake is treating the PMS plan as a static document finalised at CE marking rather than as a living plan that is updated as new post-market data, complaints, or vigilance trends emerge. Notified bodies expect evidence that the PMS plan is actually being executed and its outputs are traceable back into the performance evaluation report.

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RegulatoryRegulated Pathways Post-Market & Safety Global Markets Startup Lifecycle

Post-Market Surveillance Plan (IVDR)

Manufacturer-maintained plan under Article 79 describing how safety and performance data are systematically collected once an IVD is on the market.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026

Definition

Article 79 and Annex III of the IVDR require every manufacturer to plan, establish, document, implement, maintain, and update a post-market surveillance system proportionate to the risk class and appropriate for the type of device. The PMS Plan defines the data sources (complaints, PMPF, literature, registries), the indicators and thresholds, and the linkage back into risk management and the performance evaluation.

What the regulation says

Annex III Section 1.1 specifies the required content of the PMS Plan including proactive and reactive collection of data, methods for evaluating collected data, tools to trace and identify devices, and the effective communication with authorities and users.

What this means in practice

For Class A and B devices the outputs feed a PMS Report (Article 80); for Class C and D they feed a Periodic Safety Update Report (PSUR, Article 81) that is reviewed by the notified body for Class C and D and, for Class D, made available through EUDAMED.

Examples

For an IVD used to detect a common pathogen, the PMS Plan might specify a threshold of 10 unresolved customer complaints related to false negatives within a quarter, triggering a review by the risk management team.
A manufacturer of a novel biomarker IVD would include specific plans for analyzing scientific literature and clinical registries to monitor for emerging evidence regarding the biomarker's long-term performance and diagnostic accuracy.
The PMS Plan for a high-risk IVD, such as one used in blood screening, would detail a systematic process for collecting performance data from designated laboratories and conducting targeted post-market performance follow-up studies.

Common pitfalls

•A common mistake is creating a generic PMS Plan that does not adequately reflect the specific risks, intended use, or type of a particular IVD, failing to meet the proportionality requirement of Article 79.
•Manufacturers often fail to establish clear indicators and thresholds for when a signal constitutes a potential safety concern, leading to reactive rather than proactive post-market surveillance activities.
•Another pitfall is not ensuring a robust feedback loop from PMS activities back into the risk management process and performance evaluation, which is critical for ongoing device safety and effectiveness updates.

Frequently asked questions

The Article 79 PMS plan must describe the processes and methods the manufacturer will use to systematically collect and analyse safety and performance data from the device once it is on the market, including data collection sources, indicators and thresholds that would trigger corrective action, and how findings feed back into the risk management file and performance evaluation report.

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Regulatory

EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

Regulatory

Post-Market Performance Follow-Up (IVDR)(PMPF)

Continuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF.

Post-Market

Post-Market Surveillance(PMS)

Activities to monitor device safety and performance after market release.

Post-Market

PSUR (IVDR Specific)

Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81.

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510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

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Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.

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513(g) Request for Information(513(g))

Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

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Abbreviated 510(k)

510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.

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Manufacturer-maintained plan under Article 79 describing how safety and performance data are systematically collected once an IVD is on the market.

·The PMS Plan defines the data sources (complaints, PMPF, literature, registries), the indicators and thresholds, and the linkage back into risk management and the performance evaluation.

Remember this

Watch out: A common mistake is creating a generic PMS Plan that does not adequately reflect the specific risks, intended use, or type of a particular IVD, failing to meet the proportionality requirement of Article 79.

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