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 classes. 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 |