Post-market surveillance (PMS) — requirements by class
Regulatory basis - MDR Art. 83–86 / IVDR Art. 78–81. PMS is a proactive, systematic process that all manufacturers must implement. The depth and reporting frequency scale with device risk class.
Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
What is post-market surveillance?
Post-market surveillance (PMS) is the proactive and systematic process of collecting and analysing data on marketed devices to:
- Confirm the device's safety and performance throughout its commercial lifetime
- Identify previously unknown or underestimated risks
- Detect any systematic misuse or off-label use that could affect safety
- Determine whether improvements to the device or IFU are needed
- Ensure the benefit-risk analysis remains positive
PMS is mandatory for all manufacturers of all device classes and IVD all classes, regardless of conformity assessment route or whether notified body involvement is required. There is no exemption.
PMS system — MDR Art. 83
Manufacturers must establish, document, implement, maintain, and update a PMS system that is an integral part of the QMS. The system must:
- Actively gather post-market data from defined sources
- Analyse and evaluate the gathered data
- Draw conclusions about the need for preventive or corrective action
- Feed data back into the risk management file, clinical/performance evaluation, technical documentation, and manufacturing and labelling processes
The PMS system is not a passive complaints log — it is a proactive surveillance programme.
PMS data sources
The PMS plan must identify which data sources will be monitored and how frequently. Standard sources include:
| Source | Examples |
|---|---|
| Customer complaints and feedback | Distributor reports, direct user feedback, help desk queries |
| Vigilance data | Own serious incidents; published FSCA/recall information for comparable devices |
| Scientific literature | Systematic literature searches (PubMed, EMBASE, Cochrane) |
| Clinical registries | National implant registries, disease-specific registries |
| PMCF / PMPF studies | Structured post-market clinical/performance data collection |
| EUDAMED public data | Published vigilance reports for similar devices |
| Social media and online platforms | Patient forums, adverse event reporting channels |
| Post-market clinical follow-up (MDR) | Structured real-world data collection |
| Post-market performance follow-up (IVDR) | Ongoing analytical and clinical performance monitoring |
PMS requirements by device class
MDR Class I
| Requirement | Detail |
|---|---|
| PMS system | Required |
| PMS plan | Required |
| PMS report | Required — updated when necessary (no fixed frequency) |
| PSUR | Not required |
| PMCF | Required — but may be justified as not necessary |
| Notified body review | Not required (Class I self-declaration) |
Class I PMS is typically simpler — fewer complaints, less complex devices. But the obligation exists and must be documented.
MDR Class IIa
| Requirement | Detail |
|---|---|
| PMS system | Required |
| PMS plan | Required |
| PMS report | Required — updated at minimum when significant new information available; NB reviews at surveillance |
| PSUR | Not required (PMS report suffices) |
| PMCF | Required — must be justified if not conducted |
| Notified body review | PMS report reviewed at NB surveillance audit |
MDR Class IIb
| Requirement | Detail |
|---|---|
| PMS system | Required |
| PMS plan | Required |
| PMS report | Required |
| PSUR | Required for implantable Class IIb devices — at minimum every 2 years |
| PMCF | Required |
| Notified body review | PSUR/PMS report reviewed at annual surveillance audit |
MDR Class III / AIMD
| Requirement | Detail |
|---|---|
| PMS system | Required |
| PMS plan | Required |
| PSUR | Required — at minimum annually |
| PMCF | Required — PMCF plan and evaluation report maintained |
| Notified body review | PSUR and PMCF reviewed at annual surveillance audit; PSUR submitted to NB via EUDAMED |
IVDR PMS requirements by class
IVDR Class A
| Requirement | Detail |
|---|---|
| PMS system | Required |
| PMS plan | Required |
| PMS report | Required |
| PSUR | Not required |
| PMPF | Required — justified if not conducted |
IVDR Class B
| Requirement | Detail |
|---|---|
| PMS system | Required |
| PMS plan | Required |
| PMS report | Required |
| PSUR | Not required |
| PMPF | Required |
| NB review | At NB surveillance |
IVDR Class C
| Requirement | Detail |
|---|---|
| PMS system | Required |
| PMS plan | Required |
| PSUR | Required — at minimum every 2 years |
| PMPF | Required |
| NB review | PSUR reviewed at NB surveillance |
IVDR Class D
| Requirement | Detail |
|---|---|
| PMS system | Required |
| PMS plan | Required |
| PSUR | Required — at minimum annually |
| PMPF | Required |
| NB review | Annual review; PSUR submitted to NB |
The PMS–technical documentation feedback loop
PMS data must flow back into the technical documentation. When PMS identifies:
- New hazards: update the risk management file
- Changed risk estimates: update risk management file and benefit-risk analysis
- New clinical/performance data: update CER / performance evaluation report
- GSPR compliance concerns: update GSPR cross-reference table
- Labelling adequacy issues: update IFU and labels
This creates the lifecycle loop that is central to MDR/IVDR's approach — the technical documentation reflects the device as it is known today, not just as it was at CE marking.
Related pages
- PMS plan and PMS report — Annex III
- Annual reports / PSUR
- Distribution records
- PMCF plan and evaluation report
- Post-market overview
Official references
| Reference | Description |
|---|---|
| MDR Art. 83 | PMS system requirements |
| MDR Art. 84 | PMS plan requirements |
| MDR Art. 85 | PSUR requirements |
| MDR Art. 86 | PMS report requirements |
| IVDR Art. 78–81 | IVDR PMS requirements |
| MDR Annex III | Post-market technical documentation |
| MDCG 2022-21 | PSUR guidance |
| MDCG 2020-7 | PMCF plan and evaluation report template |
Complete the IVDR Class A table entry as: 'PMPF: Not required (PMS report suffices)' or 'PMPF: Required — must be justified if not conducted' depending on regulatory intent, and add corresponding explanatory text below the table clarifying the PMPF expectation for Class A devices.
Add complete IVDR Classes B, C, and D requirement tables with the following structure: IVDR Class B — PMS system (Required), PMS plan (Required), PMS report (Required), PMPF (Not required or Required as justified), Notified body review (PMS report reviewed at surveillance); IVDR Class C — similar structure with PSUR required at minimum every 2 years; IVDR Class D — PSUR required at minimum annually.