What post-market surveillance is
Post-market surveillance (PMS) is how a manufacturer keeps watching a device after it reaches the market: collecting data on performance and safety, detecting problems early, and feeding what it learns back into risk management, design, labeling and clinical evaluation. Clinical studies before approval involve limited patients and time; real-world use is where rare problems and misuse appear.
The term means slightly different things in different places. In the EU, PMS is a defined system under the MDR. In the US, it is a set of separate obligations: adverse event reporting, recalls, complaint handling and, for some devices, FDA-ordered postmarket studies.
For a PMS checklist covering FDA and EU MDR, see Medical Device Post-Market Surveillance Checklist: FDA and EU MDR in 2026.
Post-market obligations in the US
| Obligation | Rule | Key requirement |
|---|---|---|
| Medical device reporting (MDR) | 21 CFR 803 | Report reportable events “no later than 30 calendar days” after awareness, or within 5 work days when required (eCFR) |
| Electronic submission | 21 CFR 803.12 | Manufacturers “must submit initial and supplemental or followup reports to FDA in an electronic format” |
| Corrections and removals | 21 CFR 806 | Report “within 10-working days of initiating such correction or removal” (eCFR) |
| Section 522 postmarket surveillance | 21 CFR 822 | FDA may order studies where “Failure of the device would be reasonably likely to have serious adverse health consequences”; surveillance must start within 15 months of the order (eCFR) |
| Complaint handling | 21 CFR 820.35 and ISO 13485 clause 8.2.2 | Records of review, evaluation and investigation, with links to MDR reporting (eCFR) |
The volume is large. FDA says it receives “over two million medical device reports” each year (FDA).
Post-market surveillance under the EU MDR
The MDR requires manufacturers to “plan, establish, document, implement, maintain and update a post-market surveillance system” that is “proportionate to the risk class” (Article 83) (MDR, via Advisera).
| Element | Requirement |
|---|---|
| PMS plan | Part of technical documentation under Annex III; defines data sources, methods and indicators |
| PMS report (class I) | “Manufacturers of class I devices shall prepare a post-market surveillance report,” updated when necessary (Article 85) (Advisera) |
| PSUR (class IIa) | Updated “when necessary and at least every two years” (Article 86) (Advisera) |
| PSUR (class IIb and III) | Updated “at least annually” (Article 86) |
| Vigilance | Serious incident and field safety corrective action reporting (Articles 87 to 92) |
| Trend reporting | Report “any statistically significant increase in the frequency or severity of incidents that are not serious incidents” (Article 88) (Advisera) |
PMS findings must flow back into the clinical evaluation, risk management, labeling and, where needed, corrective action.
What changed in 2025 and 2026
- FDA consolidated adverse event systems. In March 2026, FDA launched its Adverse Event Monitoring System (AEMS), a “new unified platform for analyzing adverse event reports” replacing a “patchwork of seven databases” that “processed approximately 6 million adverse event reports per year” (FDA). RAPS reported AEMS will also replace the MAUDE device database (RAPS).
- EUDAMED modules became mandatory. Four EUDAMED modules became mandatory on May 28, 2026, including market surveillance. The vigilance and post-market surveillance module is still “in development” (European Commission), so vigilance reporting continues through national processes.
- New EU incident report form. Finland’s regulator says manufacturers “must start using the reporting form by May 2026, at the latest,” referring to MIR form version 7.3.1 (Fimea).
- Recall activity. Sedgwick’s 2026 recall index reported that medical device recall events declined 8% in 2025, even as some sectors saw increases in units affected (Sedgwick).
- FDA scrutiny of complaint trending. A January 2026 warning letter stated, “Your firm’s complaint trending process is inadequate,” and noted a reportable event for which “no MDR was received by the FDA” (FDA).
Building a PMS system that works in both markets
- Map data sources: complaints, service records, MDR and vigilance reports, literature, registries, user feedback, similar-device data and post-market clinical follow-up.
- Define indicators and thresholds for trending, including statistical methods for Article 88 trend reporting.
- Connect PMS to the QMS: complaint handling, CAPA, risk management and design change.
- Set reporting workflows for US MDRs (30-day and 5-day) and EU serious incidents, with clear decision criteria.
- Write the PMS plan and reports per Annex III and Articles 85 and 86.
- Feed results back into clinical evaluation, risk files and labeling.
- Review in management review and adjust surveillance as the device matures.
PMS readiness checklist
- PMS procedure covers US and EU obligations
- Data sources and indicators documented in the PMS plan
- Trend thresholds and statistical methods defined
- MDR and vigilance reportability criteria documented, with timelines
- eMDR submission in place for US reports
- Current EU MIR form in use
- PMS report or PSUR schedule set by device class
- PMS outputs feed CAPA, risk management and clinical evaluation
- Corrections and removals process aligned with 21 CFR 806
- AEMS and EUDAMED developments tracked
Make PMS documents consistent and complete
PMS plans, PSURs, risk files and clinical evaluations must tell the same story. AskDona checks PMS documentation against EU MDR requirements, FDA rules or your own procedure, flags gaps and inconsistencies between documents, and cites the passage behind every finding.
Run a sample PMS document assessment on a PMS plan or PSUR. AskDona shows the evidence; your regulatory team decides.
FAQ
What is post-market surveillance? The ongoing collection and analysis of data on a device’s safety and performance after it is on the market.
Is PMS required by FDA? FDA does not use a single PMS system requirement like the EU, but it requires MDR reporting, complaint handling, correction and removal reports, and Section 522 studies when ordered.
What is a PSUR? A periodic safety update report required under the EU MDR for class IIa, IIb and III devices.
How often must a PSUR be updated? At least annually for class IIb and III, and at least every two years for class IIa.
What is AEMS? FDA’s Adverse Event Monitoring System, launched in 2026 to consolidate its adverse event databases (FDA).
References
All pages opened and checked by October 13, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| eCFR: 21 CFR 803 | Regulation | Current | MDR timelines, eMDR |
| eCFR: 21 CFR 806 | Regulation | Current | Corrections and removals |
| eCFR: 21 CFR 822 | Regulation | Current | 522 surveillance |
| eCFR: 21 CFR 820.35 | Regulation | Current | Complaint records |
| FDA: MDR data files | Regulator | Sep 2, 2026 | Report volume |
| Advisera: MDR Article 83 | Regulation text reproduction | n.d. | PMS system |
| Advisera: MDR Article 85 | Regulation text reproduction | n.d. | PMS report |
| Advisera: MDR Article 86 | Regulation text reproduction | n.d. | PSUR |
| Advisera: MDR Article 88 | Regulation text reproduction | n.d. | Trend reporting |
| FDA: AEMS launch | Regulator | Mar 11, 2026 | AEMS |
| RAPS: AEMS | Professional body | Mar 11, 2026 | MAUDE replacement |
| European Commission: EUDAMED overview | Regulator | 2026 | Module status |
| Fimea: New MIR form | Competent authority | Jan 7, 2026 | MIR form |
| Sedgwick: Recall index | Industry report | Feb 19, 2026 | Recall trends |
| FDA warning letter: Beta Bionics | Regulator | Jan 28, 2026 | Complaint trending |