The MDR (Regulation (EU) 2017/745) was adopted on 5 April 2017 and has applied since 26 May 2021. Article 84 requires every manufacturer's post-market surveillance (PMS) system to be based on a PMS plan, with its content set out in Section 1 of Annex III. In December 2025 the MDCG published MDCG 2025-10, which explains each Annex III element with examples.
A PMS plan that only lists "complaints and literature" will not hold up against Annex III. This article explains where the plan sits in the MDR, what it must contain, how it links to the PMCF plan and risk management, and how it drives the PMS report or PSUR. Our article on post-market surveillance for medical devices covers the wider PMS system.
Where the plan sits in the MDR
Article 83 requires the manufacturer to plan, establish, document, implement, maintain and update a PMS system that is proportionate to the risk class and appropriate for the type of device. Article 84 then requires that system to be based on a PMS plan, which is part of the technical documentation under Annex III.
Two points from MDCG 2025-10 are useful in practice:
custom-made devices are addressed separately in section 3.2 of the guidance;
one plan may cover a group of devices, provided the scope is clearly stated (section 4).
MDCG 2025-10 is guidance, not law. The binding requirements are in the MDR articles and annexes.
In our view, the plan should stay short and refer to controlled procedures for the "how" and "who", which MDCG 2025-10 section 4 allows. The plan itself should hold the device-specific decisions: which data, which indicators, which thresholds, and what happens when a threshold is crossed. Our article on SaMD technical documentation explains where the plan sits in the technical file.
What information the plan must collect
Annex III Section 1(a) lists the information the PMS system must collect and use:
information on serious incidents, including information from PSURs, and field safety corrective actions;
records of non-serious incidents and data on undesirable side-effects;
information from trend reporting;
relevant specialist or technical literature, databases and registers;
information, including feedback and complaints, from users, distributors and importers;
publicly available information about similar medical devices.
Source: MDR Annex III Section 1(a); MDCG 2025-10 Table 2.
A source is not a method. "Literature" is a source; a documented search strategy with inclusion criteria and a search frequency is a method. The plan should describe both.
For software, in our view the plan should also name the data sources the software itself makes available, such as usage and performance data, alongside complaints and literature. MDCG 2025-10 section 4 also stresses that collection must be proactive: the manufacturer actively seeks information rather than waiting for complaints, with methods tailored to the device and justified.
What the plan must contain
Annex III Section 1(b) sets out what the plan must cover. MDCG 2025-10 Table 1 explains each element.
| Element | What to write in the plan | Source |
|---|---|---|
| Proactive and systematic collection | Data sources, collection methods and frequencies, including comparison with similar devices | Annex III 1(b); MDCG 2025-10 Table 1 |
| Assessment methods | How the data will be analysed and used to reassess the benefit-risk ratio | Annex III 1(b); MDCG 2025-10 Table 1 |
| Indicators and thresholds | Suitable indicators and threshold values, linked to the risk management documentation | Annex III 1(b); MDCG 2025-10 Table 1 |
| Complaint investigation | Methods and tools to investigate complaints and analyse market experience | Annex III 1(b); MDCG 2025-10 Table 1 |
| Trend reporting | Methods to manage events subject to Article 88, including how a statistically significant increase is established and the observation period | Annex III 1(b); Art. 88 |
| Communication | Methods and protocols for communicating with competent authorities, notified bodies, economic operators and users | Annex III 1(b) |
| Procedures | Reference to procedures meeting Articles 83, 84 and 86 | Annex III 1(b) |
| Corrective actions | Systematic procedures to identify and initiate appropriate measures, including corrective actions | Annex III 1(b) |
| Traceability | Tools to trace and identify devices for which corrective actions might be necessary | Annex III 1(b) |
| PMCF | A PMCF plan, or a justification why PMCF is not applicable | Annex III 1(b); Annex XIV Part B |
Sources: MDR Annex III; MDCG 2025-10 Table 1.
Indicators, thresholds and risk management
Article 83(3)(a) requires PMS data to be used to update the benefit-risk determination and risk management. MDCG 2025-10 Table 3 links the plan's indicators and thresholds to the risk management documentation under Annex I Section 3.
In our view, the plan should be written before launch. MDCG 2025-10 Table 1 expects indicators and threshold values to be set in the pre-market phase. If thresholds are chosen after the data arrives, there is no real test of whether the device is performing as the risk analysis assumed.
A threshold breach is not automatically a trend report. It should trigger an investigation and a risk management review, and a separate assessment of whether the Article 88 conditions for trend reporting are met. Serious incidents and field safety corrective actions follow the vigilance rules, explained in MDCG 2023-3 Rev.2.
The PMCF plan
The PMS plan must include a post-market clinical follow-up (PMCF) plan under Annex XIV Part B, or a justification for why PMCF is not applicable.
MDCG 2020-7 provides a PMCF plan template, organised in sections A to G, with activity timelines given quarterly or at least yearly. For implantable and class III devices that were not subject to a clinical investigation under the exemptions in Article 61(4), the PMCF plan should include post-market studies to demonstrate safety and performance.
PMCF findings are documented in a PMCF evaluation report (MDCG 2020-8 provides a template), which forms part of the clinical evaluation report. Our article on the clinical evaluation report covers that link.
What the plan produces: PMS report or PSUR
The plan drives the periodic output:
Class I: a PMS report under Article 85, updated when necessary and made available to the competent authority on request.
Class IIa, IIb and III: a periodic safety update report (PSUR) under Article 86. Article 86(1) requires it to include the conclusions of the benefit-risk determination, the main findings of the PMCF, and the volume of sales with an estimate of the size and characteristics of the population using the device.
| Class | PSUR frequency | Submission |
|---|---|---|
| IIa | When necessary and at least every 24 months | Made available to the notified body, and to competent authorities on request |
| IIb | At least every 12 months | Made available to the notified body, and to competent authorities on request |
| III and implantable devices | At least every 12 months (class IIa implantables: at least every 24 months) | Submitted via EUDAMED to the notified body, which adds its evaluation |
Sources: MDR Articles 85 and 86; MDCG 2022-21, Figure 2.
Submission through EUDAMED depends on the availability of the relevant module. After each PMS report or PSUR, MDCG 2025-10 section 5.4 expects the manufacturer to review the plan itself: are the sources still producing useful data, and do the indicators still make sense?
For IVDs, the equivalent requirements are in Article 79 and Annex III of the IVDR, with a post-market performance follow-up (PMPF) plan under Annex XIII Part B. Our article on post-market surveillance under the IVDR covers that regime.
A hypothetical example
Hypothetical example: a Dutch company markets software that flags possible diabetic retinopathy on retinal images. Assume it is class IIa; this example does not derive the class.
Scope: the plan names the device, its intended purpose, its Basic UDI-DI and the markets covered.
Sources (Annex III 1(a)): complaints, literature, information on similar devices, and usage and performance data available from the software.
Indicators (Annex III 1(b)): for example, the rate of user-reported missed findings, using usage data for the denominator. The threshold is set before launch from the risk analysis and recorded in the risk management file.
Trends: the plan states the method and observation period for identifying a statistically significant increase under Article 88.
PMCF: activities are planned using the MDCG 2020-7 template. A user-reported rate is not the same as diagnostic sensitivity, so clinical performance needs its own PMCF evidence.
Output: a PSUR at least every 24 months, as for class IIa devices under MDCG 2022-21.
Qualification and classification come first; our article on medical device regulatory strategy for the EU and US covers that step, and our guide to CE marking for medical devices explains where the plan fits in conformity assessment.
Conclusion
The PMS plan is the document that links market data to decisions on risk, clinical evidence and corrective action. Annex III sets out what it must contain, MDCG 2025-10 explains each element, and the PMS report or PSUR shows what the manufacturer found and decided.
In our view, a good plan is written before launch, stays short, names its sources and indicators, sets thresholds in advance and refers to procedures for the operational detail. For software, it should use the data the software already produces.
If you need help writing or reviewing your PMS plan, our post-market follow-up team can help, or contact MedQAIR.
Frequently asked questions
Do class I devices need a PMS plan?
Yes. Article 84 applies to all classes. The class changes the output: a PMS report for class I, a PSUR for class IIa, IIb and III.
Can one PMS plan cover several devices?
Yes, according to MDCG 2025-10 section 4, provided the scope is clearly stated. The plan should still justify that the indicators and thresholds suit every device it covers.
Is PMCF always required?
The PMS plan must contain either a PMCF plan or a justification for why PMCF is not applicable (Annex III and Annex XIV Part B).
What is the difference between a PMS plan and a PMCF plan?
The PMS plan covers all post-market data collection and analysis. The PMCF plan is part of it and focuses on clinical data to confirm safety and performance.
How often must the PMS plan be updated?
The MDR sets no fixed interval. MDCG 2025-10 section 5.4 expects the plan to be reviewed after each PMS report or PSUR, and whenever the device or its risks change.
