Post-market data in technical documentation
MDR Annex III and IVDR Annex III define the post-market technical documentation requirements. Key documents are the PMS plan, PMS report / PSUR, and PMCF plan and evaluation report (MDR) or PMPF plan and evaluation report (IVDR).
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.
Why post-market data belongs in technical documentation
Under MDR and IVDR, technical documentation is not static — it evolves throughout the device lifecycle as real-world evidence accumulates. Annex III makes this explicit by requiring a dedicated post-market section of the technical file covering:
- The plan for gathering post-market data (PMS plan)
- The results of that data gathering (PMS report or PSUR)
- The clinical/performance follow-up plan and its evaluation (PMCF/PMPF)
Critically, post-market data must feed back into pre-market documentation: the clinical evaluation report, risk management file, and benefit-risk analysis must be updated when significant post-market information emerges, ensuring the technical file remains current throughout the device lifecycle.
Post-market surveillance plan (PMS plan)
The PMS plan is a proactive document setting out how the manufacturer will systematically collect and analyse post-market information. It must address:
| Data source | Examples |
|---|---|
| Complaints and feedback | Customer complaints, user feedback, help desk queries |
| Vigilance data | Serious incidents, near-misses (own device and competitor devices) |
| Peer-reviewed literature | Systematic literature searches for the device type and clinical area |
| Registries | National implant registers, disease registries, device databases |
| PMCF/PMPF studies | Structured post-market clinical or performance follow-up activities |
| EUDAMED data | Vigilance reports for similar devices |
| Regulatory authority communications | Field safety notices, market surveillance actions |
The PMS plan must specify:
- The post-market objectives (what the manufacturer is monitoring for)
- The data sources and search methodology
- The frequency of data review and report update
- Thresholds and criteria for triggering a reactive response (e.g. CAPA, FSCA)
- Linkage to risk management (how PMS data updates the risk file)
PMS report vs. PSUR
| Document | When required | Frequency |
|---|---|---|
| PMS report | Class I, IIa, IIb (MDR); Class A, B (IVDR) | Updated when necessary; at minimum when significant new information available |
| Periodic Safety Update Report (PSUR) | Class IIb (implantable), III, AIMD (MDR); Class C, D (IVDR) | At minimum annually for Class III/D; at minimum every 2 years for Class IIb/C |
PSUR content requirements (MDR Annex III §2)
A PSUR must include:
- Device identification: name, models, basic UDI-DI, ARTG/EUDAMED reference
- Intended purpose: statement of intended use as CE marked
- Lifecycle production data: cumulative devices placed on market; estimated number in use; geographic distribution
- Summary of PMS activities and results: outcome of literature searches, complaint trends, vigilance reports, registry data, PMCF findings
- Main findings: what the PMS data shows about safety and performance
- Benefit-risk analysis conclusions: whether the benefit-risk remains positive based on accumulated evidence
- Conclusions: overall conclusions on safety, performance, and need for any actions
- Actions taken: any preventive or corrective actions arising from PMS data
PSURs are submitted to the notified body and uploaded to EUDAMED.
Post-Market Clinical Follow-up (PMCF) — MDR
PMCF is the ongoing process of proactively collecting clinical data on CE-marked devices to confirm their continued safety and performance. It is required for all MDR devices (Class I–III) and must be justified if concluded not necessary.
PMCF plan
The PMCF plan must define:
- The general methods for PMCF (literature, registries, surveys, studies)
- Specific methods: PMCF studies or surveys, if needed
- The rationale for the chosen methods relative to the device's risk class and clinical evidence gaps
- Timelines and milestones
PMCF evaluation report
The PMCF evaluation report records the outcomes of PMCF activities, including:
- Results of literature searches
- Outcomes of PMCF studies (if conducted)
- Registry data findings
- Any new safety signals or performance deviations
- Whether PMCF findings require updating the clinical evaluation report or risk management file
The PMCF evaluation report is a key input to the clinical evaluation report — PMCF data must be reflected in the CER's conclusions.
Post-Market Performance Follow-up (PMPF) — IVDR
PMPF is the IVDR equivalent of PMCF — the ongoing process of collecting and evaluating post-market performance data for IVDs. Comparable structure:
- PMPF plan: proactive plan for data collection methods (literature, proficiency testing, registries, field studies)
- PMPF evaluation report: results of PMPF activities, fed back into the performance evaluation report
PMPF is particularly important for:
- IVDs where analytical performance may drift (reagent lots, platform updates)
- IVDs where clinical performance data was limited at time of CE marking
- Companion diagnostics where the drug-device therapeutic context evolves
The feedback loop: post-market to pre-market documents
PMS data / PMCF / PMPF results
↓
PSUR / PMS report conclusions
↓
┌────────────────────────────────┐
│ │
↓ ↓
Clinical Evaluation Report Risk Management File
(update safety/performance (update hazard estimates,
conclusions if needed) residual risks, B/R analysis)
↓ ↓
┌────────────────────────────────┘
↓
GSPR cross-reference table
(update if new evidence affects GSPR compliance)
This loop is what makes MDR/IVDR a lifecycle regulatory framework rather than a one-time certification. The technical documentation must reflect the device as it is, based on current evidence — not just as it was at initial certification.
Notified body review of Annex III documents
For Class IIb, III, and IVDR Class C and D devices, notified bodies review the PSUR and PMCF/PMPF evaluation reports as part of their surveillance activities. They look for:
- Consistency between PSUR conclusions and clinical evaluation report
- Evidence that PMS data has genuinely informed risk management
- Completeness of the literature search methodology
- Whether PMCF/PMPF methods are adequate for the device's risk and evidence gaps
- Timely escalation of safety signals through the vigilance system
Related pages
- Technical documentation — overview
- Risk management
- Clinical evaluation
- PMS requirements
- PSUR by class and frequency
- PMCF plan and evaluation report
Official references
| Reference | Description |
|---|---|
| MDR Annex III | Post-market technical documentation |
| IVDR Annex III | IVDR equivalent |
| MDR Art. 83–86 | PMS system requirements |
| MDR Art. 85 | PSUR requirements |
| MDR Art. 61(11) | PMCF requirements |
| MDCG 2020-7 | PMCF plan and evaluation report templates |
| MDCG 2022-21 | PSUR guidance |
Complete the PMCF plan section with: 'Risk acceptability criteria: how safety/performance will be assessed post-market Sample size and duration: justification for the proposed follow-up scope Evaluation methods: how data will be analysed Linkage to clinical evaluation: how PMCF findings update the clinical evaluation report Timescale: when results will be reported to the notified body PMCF evaluation report The PMCF evaluation report must include: Summary of PMCF activities conducted: methods used, patient numbers, follow-up duration Main findings: safety and performance data from PMCF sources Conclusion: whether the device continues to meet safety and performance expectations Actions: any changes to labelling, IFU, or risk management based on PMCF evidence'