One device, two surveillance systems
US and EU post-market surveillance share a goal, catching problems early, but the obligations differ. In the US, the core rules are event reporting, field actions and, when ordered, studies and tracking. In the EU, the MDR requires a proactive PMS system for every device.
For a full guide to FDA and EU MDR post-market surveillance requirements, see Post-Market Surveillance for Medical Devices: FDA and EU MDR Requirements in 2026.
US requirements
| Rule | What it requires |
|---|---|
| Part 803 MDR | 30-day reports for deaths, serious injuries and reportable malfunctions; 5-work-day reports when remedial action is needed; electronic submission |
| Part 806 corrections and removals | Report “within 10-working days of initiating such correction or removal”; keep records of unreported ones |
| Part 822 section 522 studies | When ordered: submit a plan “within 30 days” and start surveillance “not later than 15 months” after the order |
| Part 821 tracking | When ordered: keep records “for the useful life of each tracked device” |
| QMSR | Complaint records under § 820.35 and feedback into risk management |
EU MDR requirements
| Article | Requirement |
|---|---|
| 83 | A PMS system “proportionate to the risk class” for each device |
| 84 | A PMS plan per Annex III section 1.1 |
| 85 | Class I: PMS report, “updated when necessary” |
| 86 | PSUR: class IIb and III “at least annually”; class IIa “when necessary and at least every two years” |
Source: MDR Articles 83–86 as reproduced by Advisera; official text on EUR-Lex.
What’s changing in 2026
- FDA’s new adverse event system. FDA launched AEMS in March 2026 and planned to replace MAUDE for devices (RAPS). Confirm the current device cutover status on FDA’s site.
- New EU PMS guidance. MDCG 2025-10 (December 2025) says PMS “must continue throughout the device’s lifetime” and planning “commences during the device design and development phase.” It excludes PSURs and PMS reports from its scope (Emergo by UL).
- Possible PSUR relief. The Commission’s December 2025 proposal would move class IIb and III PSURs to the first year after certification and every two years thereafter, and make class IIa PSURs “when necessary” (NAMSA). It is still a proposal.
- EUDAMED. The first modules became mandatory on May 28, 2026; the vigilance and PMS module is not yet mandatory (TÜV NORD).
Post-market surveillance checklist
System and planning
- PMS procedure covers both FDA and EU obligations for each market
- EU PMS plan per device (or device family), started during design and development
- Data sources defined: complaints, service, MDRs and vigilance reports, literature, registries, similar devices, user feedback
- Roles, frequencies and trend thresholds defined
Event reporting
- MDR reportability assessed for every complaint, with documented rationale
- 30-day and 5-work-day clocks tracked from the become-aware date
- EU serious incidents and field safety corrective actions reported per MDR vigilance rules
- Corrections and removals assessed and reported under Part 806 within 10 working days
Analysis and action
- Complaint and incident trends analyzed against thresholds
- PMS data feeds the risk management file and clinical evaluation
- Signals trigger CAPA, design changes or labeling updates
Reports
- PSUR (class IIa, IIb, III) or PMS report (class I) updated on schedule
- PSURs for class III and implantable devices submitted to the notified body
- Section 522 study plans and reports on time, if ordered
Records and systems
- Device tracking records maintained, if ordered
- EUDAMED registrations consistent with technical documentation
- Records retained for required periods
Keep PMS documents aligned
PMS plans, PSURs, risk files and clinical evaluations must tell the same story. AI document assessment can compare them against FDA and MDR requirements, flag missing data sources or outdated conclusions, and cite the passage behind every finding.
Run a sample regulatory document assessment on one PMS plan and PSUR. AskDona shows the evidence; your PMS team decides.
FAQ
What are FDA’s main postmarket requirements for devices? MDR reporting (Part 803), reports of corrections and removals (Part 806), and, when ordered, postmarket surveillance studies (Part 822) and tracking (Part 821).
How often must an EU PSUR be updated? At least annually for class IIb and III devices, and when necessary and at least every two years for class IIa (Advisera, MDR Art. 86).
Will PSUR frequency change? The Commission has proposed reducing it, but the proposal is not yet law (NAMSA).
What is MDCG 2025-10? EU guidance on post-market surveillance under the MDR and IVDR, issued December 2025 (Emergo by UL).
References
All pages opened and checked by October 9, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| eCFR: Part 803 | Regulation text | Current | MDR |
| eCFR: Part 806 | Regulation text | Current | Corrections and removals |
| eCFR: Part 822 | Regulation text | Current | 522 studies |
| eCFR: Part 821 | Regulation text | Current | Tracking |
| EUR-Lex: Regulation (EU) 2017/745 | Regulation | 2017 | MDR official text |
| Advisera: MDR Article 86 | Regulation text copy | Current | PSUR frequency |
| RAPS: FDA consolidates adverse event systems | Trade press | Mar 11, 2026 | AEMS |
| Emergo by UL: MDCG 2025-10 | Consultancy | Dec 31, 2025 | PMS guidance |
| NAMSA: COM(2025) 1023 | Consultancy | Jun 17, 2026 | PSUR proposal |
| TÜV NORD: EUDAMED modules | Notified body | Mar 24, 2026 | EUDAMED dates |