The IVDR was adopted on 5 April 2017 and has applied since 26 May 2022 (Regulation (EU) 2017/746). In December 2025, the Medical Device Coordination Group published MDCG 2025-10, its first post-market surveillance guidance covering both medical devices and IVDs. On 16 December 2025, the European Commission also published a proposal to amend the MDR and IVDR, including a change to PSUR frequency. That proposal isn't adopted law.
For an IVD, post market surveillance under the IVDR is a lifecycle system that must keep the performance evaluation current. This guide connects the required system and plans to reporting, signal assessment, software IVD data, and the evidence manufacturers need to defend their decisions.
Why IVDR Post-Market Surveillance Matters
A complaint log is the easiest part of a PMS system to build, and the part manufacturers most often mistake for the whole job. Article 78 requires manufacturers to use market experience to assess quality, performance and safety throughout the device's lifetime, then connect that evidence to product and regulatory decisions. A complaint stored in a customer-support tool, with no documented assessment against the device's stated performance, fails that test.
The anchor for all of this is the device's stated performance. What the assay claims to measure, and how well it claims to measure it, determines which data sources matter, what PMPF activities must confirm, which trends warrant reporting, and whether a signal carries safety significance. Two IVDs in the same risk class can legitimately need different surveillance designs because their performance claims differ.
Three documents shape this work, and they carry different weight. The IVDR is binding law. MDCG 2025-10 is guidance, a practical interpretation of PMS planning and outputs, nothing more. The Commission's proposal to simplify the MDR and IVDR rules, published on 16 December 2025 as COM(2025) 1023, would change PSUR frequency if adopted. Until adoption, current IVDR requirements apply in full.
The MDR runs a parallel PMS framework for medical devices, covered in our guide to post market surveillance for medical devices; MDCG 2025-10 addresses both. The obligations that matter here are the IVDR's. Each signal assessed, each trend reported and each vigilance decision should trace back to a performance claim, with the reasoning documented. That traceability is what an auditor will test.
Build the PMS System
Article 78 hinges on one word: proportionate. Each device needs a PMS system that is documented, implemented, maintained and updated, scaled to its risk class and suited to its type, and the only defensible way to scale it is from the device's stated performance. That claim sets what counts as relevant data, how much of it the manufacturer must chase, and how sensitive the review thresholds should be. The system must actively and systematically gather, record and analyse quality, performance and safety data over the device's lifetime (Art. 78(1)–(2)). MDCG 2025-10 sections 3 and 6 explain how that system connects to the manufacturer's quality management system and technical documentation (MDCG 2025-10).
The regulatory test is whether the manufacturer can show that relevant information entered a controlled assessment process and produced a reasoned conclusion, not merely whether data exists somewhere. Choose sources for their power to expose a failure of the claimed performance: complaints and serious-incident records for clinical behaviour, non-conformities for manufacturing drift, scientific literature for the state of the art, distributor and user feedback for real-world use, and connected software data where the device generates it.
Article 78(3) defines where the system's outputs must land. In practice they feed:
Conclusions on safety and performance, with preventive or corrective action where indicated.
Updates to design and manufacturing information, instructions for use and labelling.
The performance evaluation under Article 56 and the summary of safety and performance under Article 29.
Decisions on field safety corrective action, usability, performance and safety improvements.
Trend detection under Article 83.
A recurring result pattern can cut through all of these at once. If complaints show results drifting near a claimed detection limit, the record should show which data arrived, who assessed it, what benefit-risk conclusion followed, and which controlled documents changed as a result.
Write the PMS and PMPF Plans
The PMS system is the operating process. The PMS plan describes how that process will work for the device or a justified device group. Article 79 and Annex III Section 1 place the plan within the technical documentation. MDCG 2025-10 confirms that one plan may cover a group of devices if it adequately covers that group and its PMS obligations.
Annex III Section 1(a) calls for the sources of information, while Section 1(b) specifies the plan's elements. The design work should answer practical questions: which sources will be collected proactively, how will similar devices be identified for comparison, and what methods, indicators and thresholds will prompt review? It should also define complaint-investigation methods, the approach to Article 83 trend analysis, communications, device traceability and corrective-action procedures.
A plan that lists data sources without explaining how the manufacturer will evaluate them leaves the central regulatory question unanswered. The threshold for review should relate to the device's stated performance and risks, and the method should make clear how exposure or denominator data will be considered. For software, records should distinguish relevant device versions so that a change in results can be assessed against the software in use.
PMPF is a separate part of the evidence strategy. Annex XIII Part B requires a PMPF plan or a documented justification explaining why PMPF isn't applicable. PMPF findings feed the performance evaluation; for software IVDs, MDCG 2020-1 section 4.6 identifies connected real-world data as a possible source for evaluating scientific validity, analytical performance and clinical performance (MDCG 2020-1). The data still needs a defined purpose and assessment method. It isn't enough to collect usage analytics and call them PMPF.
For a wider discussion of how software evidence fits into technical documentation, see MedQAIR's guide to SaMD technical documentation.
Select the Required Reports
IVDR class decides the report. Class A and B devices require a PMS report under Article 80; Class C and D devices require a PSUR under Article 81.
| Class | Report | Article |
|---|---|---|
| A | PMS report | Art. 80 |
| B | PMS report | Art. 80 |
| C | PSUR | Art. 81 |
| D | PSUR | Art. 81 |
Source: Regulation (EU) 2017/746, Articles 80 and 81.
The report is a snapshot of a working surveillance system. Its content only carries weight if the data behind it was collected against the device's stated performance, because the same analytical and clinical claims that set your collection thresholds also define what the report must demonstrate.
A PMS report summarises the results and conclusions of the analysis and states the rationale for, and description of, any preventive or corrective actions taken. The manufacturer updates it in line with the PMS plan, earlier where the data demands it, and makes it available to the competent authority on request (Art. 80; MDCG 2025-10, Annex 1).
Class C and D IVDs sit on an annual PSUR cycle under the current requirement described in SWD(2025) 1050. The Commission proposal would move this to a two-year frequency. Treat that as a proposal and plan resources on the annual obligation until it is adopted. MDCG 2022-21 concerns MDR PSURs and expressly excludes IVDs. Use it as a presentation aid if your team finds the format helpful, and anchor every content decision in Article 81.
For class D devices, Article 81(2) requires the PSUR to be submitted to the notified body through the electronic system; for class C devices, the PSUR is made available to the notified body and, on request, to competent authorities.
Detect and Report Safety Signals
Start with the performance stated in the product information. MDCG 2023-3 Rev.2 Q9 explains that erroneous results already documented and quantified there are expected erroneous results and are relevant to trend reporting. In our view, these belong in Article 83 trend analysis, not individual incident reports because the result occurred. Unexpected results, or a change in their frequency or severity, need a separate assessment against the facts and applicable reporting criteria.
For serious incidents and field safety corrective actions, apply Article 82. The reporting periods are 15 calendar days for a serious incident, 2 calendar days for a serious public health threat, and 10 calendar days for a death or unanticipated serious deterioration in a person's state of health. The period runs from awareness of the event. Article 82(1)(b) includes FSCAs undertaken in third countries for a device also made available on the Union market, and Article 82(7) says to report where there is doubt about whether an incident is reportable (MDCG 2023-3 Rev.2).
Article 83 requires manufacturers to report any statistically significant increase in the frequency or severity of incidents that are not serious incidents, or of expected erroneous results, that could have a significant impact on the benefit-risk analysis. The manufacturer must use the trend method defined in its PMS plan, investigate the signal and record why it did or did not lead to action. Article 84 covers the analysis of serious incidents and field safety corrective actions, including the required content of a field safety notice under Article 84(8); Article 85 covers the analysis of vigilance data; and Article 87 the electronic system on vigilance and post-market surveillance.
A field safety notice should communicate the relevant risk and action clearly to affected users, and its content should be consistent with the underlying investigation and corrective action. The discipline is the same throughout: document the decision, not just the event.
Apply the System to Software IVDs
Hypothetical example: a Dutch start-up develops a smartphone app that reads a photograph of a self-test strip and returns a semi-quantitative result, similar in concept to the software example in MDCG 2020-1 Annex II, example c. The PMS plan should identify complaints, scientific literature and connected real-world performance data as sources, with thresholds tied to the stated performance. Its PMPF plan should address scientific validity, analytical performance and clinical performance.
Suppose the investigation identifies misreads. The manufacturer should distinguish the app's software version, the input population and relevant use context, then compare the result with the performance stated in product information. A misread outside that stated performance that causes serious harm requires assessment under Article 82. An erroneous result within stated performance may instead be assessed through the Article 83 trend method, with the reporting decision based on the applicable criteria and evidence.
The device class isn't specified here, so no classification should be inferred. If the product is Class B, the reporting route is Article 80; if it is Class C or D, it is Article 81. In either case, the PMS output should connect the signal to any change in risk management, performance evaluation, labelling or software controls. Version-level evidence also supports a defensible assessment of whether a result pattern reflects the device's stated performance or a change in software behaviour.
The manufacturer should preserve traceability between the device identity, the software version and the relevant records. Our EUDAMED and UDI registration checklist covers how to keep device identifiers aligned.
Prepare for Audit and Keep Evidence Current
If complaints remain trapped in support software, nobody owns the thresholds, or reports cannot be traced to conclusions, the PMS system isn't audit-ready. The evidence should show a continuous chain from the plan to the action, with a clear rationale when the manufacturer decides that no action is needed.
Check that the file contains:
The current PMS plan and PMPF plan, or a documented justification for PMPF not being applicable.
Controlled signal, complaint and trend registers, with investigations linked to device identity and software versions.
Vigilance submissions and field safety notices, where applicable.
The current PMS report or PSUR, with benefit-risk and risk-control decisions.
CAPA links and resulting updates to the performance evaluation, Article 29 summary of safety and performance, labelling, instructions for use and technical documentation.
For legacy IVDs, MDCG 2022-8 states that Chapter VII applies and that the Article 80 PMS report is the minimum PMS requirement during the transition. The applicable legacy status doesn't remove the need for a functioning surveillance process (MDCG 2022-8).
Conclusion
The strongest IVDR PMS systems are organised around the performance the manufacturer claims. That basis determines which data matter, how PMPF contributes, whether an erroneous result is expected, and whether evidence supports a trend, vigilance report or product change. A plan that can't connect those decisions to controlled records is paperwork, not an effective lifecycle system.
If you need support building or reviewing an IVDR PMS system, our postmarket follow-up team can help, or contact MedQAIR.
Frequently asked questions
Do Class A IVDs need a PMS plan?
Yes. Article 79 and Annex III Section 1 require a PMS plan as part of the technical documentation. Article 80 sets the PMS report requirement for Class A and B devices.
Is a PSUR required for Class B IVDs?
No. Class B IVDs require a PMS report under Article 80; PSURs under Article 81 apply to Class C and D IVDs. MDCG 2025-10 provides guidance on the reporting framework.
What is the serious-incident reporting deadline?
The deadline is 15 calendar days, reduced to 2 days for a serious public health threat or 10 days for death or unanticipated serious deterioration. Article 82(3)–(5) sets these periods, measured from awareness.
Is PMPF always needed?
The manufacturer must establish a PMPF plan under Annex XIII Part B or document why PMPF isn't applicable. MDCG 2025-10 Table 3 describes PMPF aims, while MDCG 2020-1 section 4.6 discusses software IVD performance data.
What is an expected erroneous result?
An erroneous result that is already documented and quantified in the product information, for example within the stated sensitivity or specificity. According to MDCG 2023-3 Rev.2, these are handled through trend reporting under Article 83 rather than as individual incident reports.
