How do manufacturers meet their PMS obligations under MDR and IVDR without audit findings?
We build post-market surveillance systems for medical devices and in vitro diagnostics: a PMS plan under MDR (EU) 2017/745 Annex III, a PSUR under Art. 86, PMCF under Annex XIV, plus the IVDR counterparts under EU 2017/746. The real difficulty is not the document but the data flow: PMS only works when complaints, vigilance reports and literature feed into a single evaluation that genuinely informs risk management under ISO 14971. Otherwise the notified body has an easy-to-find gap in the surveillance audit.
- MedTech
- IVD
Overview
What PMS requirements do MDR and IVDR impose?
PMS for MedTech & IVD · MDR (EU 2017/745) and IVDR (EU 2017/746), Classes I-III, ISO 14971:2019
Last updated: 2026-06-12
The Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746 make post-market surveillance a documented obligation across the entire product lifecycle, not an optional add-on. The points where manufacturers most often get caught in an audit:
- A mandatory PMS plan for every product under MDR Art. 84 or IVDR Art. 79, defining data sources, evaluation methods and reporting intervals and forming part of the technical documentation under MDR Annex III.
- A PSUR under MDR Art. 86 for Class IIa to III, or IVDR Art. 81 for Class C and D, with an update interval that depends on the risk class; for Class I or Class A/B a PMS report under Art. 85 or Art. 80 is sufficient.
- Clinical follow-up after market launch: PMCF under MDR Annex XIV Part B for medical devices, and the counterpart PMPF under IVDR Annex XIII Part B for in vitro diagnostics.
- Systematic evaluation of complaints, vigilance reports under Art. 87 et seq. and literature, fed back into risk management under ISO 14971:2019. PMS is a continuous feedback loop, not a one-off document.
Services
How we support you
PMS plan under MDR/IVDR
A product-specific PMS plan under MDR Art. 84 or IVDR Art. 79 with defined data sources, evaluation methods, trending thresholds and reporting intervals, embedded in the technical documentation under MDR Annex III.
PSUR & PMS report
Preparation of the PSUR under MDR Art. 86 for Class IIa-III or IVDR Art. 81 for Class C/D, as well as the PMS report under Art. 85 or Art. 80 for the lower classes, each with a documented conclusion on the benefit-risk ratio.
PMCF / PMPF & registry data
PMCF plan and report under MDR Annex XIV Part B, or PMPF under IVDR Annex XIII Part B: clinical follow-up studies, registries and systematic literature review, fed back into the Clinical Evaluation Report.
Learn more →PMS system setup & SOPs
Implementation of a PMS system under MDR Art. 83 or IVDR Art. 78 with processes, responsibilities and data integration into complaint and vigilance handling, guided by ISO/TR 20416:2020.
Signal detection & trending
Setting up complaint trending and signal detection from field data, with defined thresholds and escalation paths to vigilance under Art. 87 et seq.
Learn more →Integration with risk management
Feeding PMS results back into the risk management file under ISO 14971:2019, so that new field data demonstrably updates the risk assessment and the benefit-risk ratio.
Learn more →How we work together
What it comes down to
Post-market surveillance under the MDR (EU) 2017/745 and the IVDR (EU) 2017/746 is not a final document but a feedback loop that only works when its parts engage in the right order. First, the PMS plan under MDR Art. 84 or IVDR Art. 79 must define which data sources feed in at all and against which thresholds they are evaluated. Only then is it worth building complaint trending and signal detection, because without a defined methodology the evaluation produces numbers without a yardstick for assessment. And only from that evaluation do the PSUR under Art. 86 or Art. 81 and the clinical counterparts PMCF under Annex XIV Part B, or PMPF under IVDR Annex XIII Part B, emerge. Anyone who builds the system back to front and writes the PSUR before the data flow is in place fills a report with assumptions instead of substantiated field data.
The critical point lies at the interface with risk management under ISO 14971:2019. MDR Art. 83 requires PMS results to demonstrably update the risk assessment and the benefit-risk ratio. If the risk management file stays unchanged despite new field data, the feedback loop is formally broken, and that gap is the quickest to find in the surveillance audit. That is why we start with the data integration and the feedback loop before any reports are written: this way PSUR and PMCF/PMPF emerge from an ongoing system rather than as after-the-fact documents that the audit exposes as hollow.
Our approach
Our approach
Step
Result
Gap assessment
An overview of existing PMS documents, data sources and gaps for each product class, with a prioritized action list.
PMS plan
A product-specific PMS plan under MDR Art. 84 or IVDR Art. 79 with data sources, methods and intervals, filed in the technical documentation.
System setup
PMS processes, SOPs and responsibilities under MDR Art. 83 or IVDR Art. 78, connected to complaint and vigilance handling.
Data evaluation
Structured evaluation of complaints, vigilance reports and literature with trending and signal detection.
Reporting
PSUR or PMS report at the prescribed interval, PMCF/PMPF report and a documented benefit-risk conclusion.
Feedback loop
An updated risk management file under ISO 14971:2019 and, where necessary, revised technical documentation and clinical evaluation.
Common pitfalls
Where projects commonly fail
The PMS plan exists as a document, but no data flow feeds it.
Complaints, vigilance reports and literature end up in separate repositories instead of in a single evaluation. The notified body checks exactly this linkage in the surveillance audit and spots the gap immediately.
PMS results are not fed back into risk management.
MDR Art. 83 requires new field data to update the risk assessment and the benefit-risk ratio; if the risk management file under ISO 14971:2019 stays unchanged, the feedback loop is formally broken.
PMCF and PMPF are confused, or the wrong annex is cited.
PMCF applies to medical devices under MDR Annex XIV Part B; the counterpart for in vitro diagnostics is PMPF under IVDR Annex XIII Part B. An IVD manufacturer who submits a PMCF plan shows that the IVDR logic has not been understood.
The PSUR interval is chosen based on the wrong class.
MDR Art. 86 and IVDR Art. 81 stagger the update by risk class; a PSUR produced too infrequently, or a missing justification of the benefit-risk ratio, leads to deficiency requests.
PMS is treated as a final document for initial certification and is not maintained afterwards.
Annex III requires a continuously updated system; a frozen PMS plan with no documented data evaluation will be flagged at the recertification audit at the latest.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR) - primary text, Art. 83-92, Annex III, Annex XIV Part B
- Regulation (EU) 2017/746 (IVDR) - primary text, Art. 78-81, Annex XIII Part B
- ISO 14971:2019 - Application of risk management to medical devices
- ISO/TR 20416:2020 - Post-market surveillance for manufacturers
- Writer source file: output/expertise-pages/regulatory-compliance/post-market-surveillance/post-market-surveillance.md
- https://theentourage.de/expertise/post-market-surveillance/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR)
- MDR Art. 83 (manufacturer's PMS system)
- MDR Art. 84 (PMS plan)
- MDR Art. 85 (PMS report, Class I)
- MDR Art. 86 (PSUR, Class IIa-III)
- MDR Art. 87-92 (vigilance and reporting obligations)
- MDR Annex III (technical documentation on post-market surveillance)
- MDR Annex XIV Part B (PMCF)
- EU 2017/746 (IVDR)
- IVDR Art. 78 (PMS system)
- IVDR Art. 79 (PMS plan)
- IVDR Art. 80 (PMS report, Class A and B)
- IVDR Art. 81 (PSUR, Class C and D)
- IVDR Annex XIII Part B (PMPF)
- ISO 14971:2019 (risk management)
- ISO/TR 20416:2020 (post-market surveillance for manufacturers)
Related topics
Medical Device Vigilance →
Reactive reporting obligation under MDR Art. 87 et seq. as the counterpart to proactive PMS
MDR Conformity →
PMS as a mandatory part of MDR conformity under EU 2017/745
IVDR Readiness →
PMS, PSUR and PMPF obligations for in vitro diagnostics under EU 2017/746
Risk Management →
Feeding PMS results back into the risk management file under ISO 14971:2019
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