PMS · PMCF · PSUR
PMS and PMCF software that feeds back into risk and clinical evaluation
PMS and PMCF software helps a manufacturer run post-market surveillance as MDR Articles 83 to 86 require: a PMS plan for each device, proactive post-market clinical follow-up (Annex XIV Part B), and periodic reporting in a PMS report for Class I devices or a periodic safety update report (PSUR) for Class IIa, IIb and III devices. MDRpilot generates these documents from the product record, schedules the PSUR by class and keeps complaints, CAPA and the risk file in the same workspace, so post-market findings can update risk and clinical evaluation.
Who it is for
- Post-market and vigilance teams
- Manufacturers of Class IIa, IIb and III devices with PSUR obligations
- Teams that need a PMCF plan for a CER gap
Key capabilities
PMS plan
Drafted from product data, with data sources, indicators and responsibilities.
PMCF plan and survey
PMCF plan structured along MDCG 2020-7, plus a PMCF survey you can use to collect user feedback.
PSUR or PMS report
Outline and frequency set by the device class.
Complaints and CAPA
Operational records that feed the post-market data summary.
DOCX export
PMS and PMCF documents export for the technical file.
Which post-market document applies
| Device class | Periodic document |
|---|---|
| Class I | PMS report, updated when necessary (Article 85) |
| Class IIa | PSUR, updated when necessary and at least every two years (Article 86) |
| Class IIb | PSUR, updated at least annually (Article 86) |
| Class III and implantable | PSUR at least annually, submitted to the notified body through EUDAMED (Article 86(2)) |
What a PMS plan needs
- Sources of data: complaints, vigilance, literature, registries, user feedback, similar devices
- Indicators and threshold values that trigger a reassessment of benefit-risk
- Methods for complaint and trend analysis, including trend reporting under Article 88
- Procedures for corrective and preventive actions
- A PMCF plan, or a justification for why PMCF is not needed
How the workflow runs
- 1
Plan
Create the PMS plan and decide on PMCF.
- 2
Collect
Log complaints, vigilance events and survey results.
- 3
Analyse
Review trends against your thresholds.
- 4
Act
Open CAPA and update the risk file.
- 5
Report
Prepare the PSUR or PMS report and update the CER.
Connected to the rest of the file
MDRpilot is not a stand-alone document generator. Requirements, evidence and documents share one product record.
Each step reads from the same product record. A test report linked to a GSPR row can verify a risk control, a change to the device class flags the documents that depend on it, and the audit readiness view counts what is still open across all of them.
Limitations
- MDRpilot does not submit vigilance reports or PSURs to EUDAMED or competent authorities.
- Survey design and statistical analysis of PMCF data remain your responsibility.
- Thresholds for trend reporting must be set by your team.
MDRpilot is documentation and workflow software. It is not a medical device, not a notified body and not a regulatory authority. It does not certify devices or guarantee compliance; AI-generated drafts must be reviewed and approved by qualified people in the manufacturer's organisation.
Frequently asked questions
What is the difference between PMS and PMCF?
PMS is the overall system for collecting and analysing post-market data. PMCF is the part of PMS that proactively collects clinical data on the device in use, described in Annex XIV Part B.
Does every device need a PSUR?
Class IIa, IIb and III devices need a PSUR. Class I devices need a PMS report instead.
Can MDRpilot help with PMCF?
It drafts the PMCF plan, provides a PMCF survey and links the plan to clinical gaps found in the clinical evaluation.
Does MDRpilot handle vigilance reporting?
It records vigilance and FSCA events as quality records. Submission to authorities through national systems or EUDAMED is done outside MDRpilot.
How does PMS connect to the risk file?
Complaints and PMS findings sit in the same workspace as the ISO 14971 risk file, so you can review risk estimates against real-world data.
Related workflows
- Clinical evaluation software for the CEP, literature and CERPlan and document MDR clinical evaluation: CEP, literature search in PubMed and Europe PMC, equivalence, clinical gap matrix and CER with review and approval.Read more
- CAPA software that closes the loop with complaints, audits and riskRun corrective and preventive actions under ISO 13485 clause 8.5: sources, root cause, actions, effectiveness checks and links to complaints, audits and risk.Read more
- ISO 14971 risk management software connected to your evidenceMaintain an ISO 14971:2019 risk management file per device: plan, hazard analysis, risk controls, verification of controls and benefit-risk, linked to GSPR and PMS.Read more
- Software for the obligations in Regulation (EU) 2017/745Software support for the obligations in Regulation (EU) 2017/745: Article 10 manufacturer duties, Annex I GSPR, Annex II/III documentation, clinical evaluation and PMS.Read more
- Audit readiness for MDR and ISO 13485 auditsPrepare for notified body and internal audits with a readiness score, a list of missing actions across technical file, QMS and CAPA, and an audit simulator.Read more
Guides and resources
- PMS and PMCF ExplainedPost-market surveillance and post-market clinical follow-up under the EU MDR: PMS system, PMS plan, PMS report and PSUR, PMCF plan and report, vigilance and trend reporting.Read more
- Clinical Evaluation Report (CER) GuideHow to plan and write an MDR clinical evaluation report: CEP contents, data sources, literature search, appraisal, equivalence, sufficiency, PMCF and updates.Read more
- Medical Device CAPA GuideHow to run CAPA under ISO 13485 clause 8.5 and MDR: when to open a CAPA, root cause analysis, actions, verification, effectiveness checks and links to risk and PMS.Read more
References
- Regulation (EU) 2017/745 on medical devices (MDR) — EUR-Lex, Publications Office of the European Union.
- MDCG 2020-7 Post-market clinical follow-up (PMCF) plan template — Medical Device Coordination Group. Listed under clinical investigation and evaluation.
- MDCG 2020-8 Post-market clinical follow-up (PMCF) evaluation report template — Medical Device Coordination Group. Listed under clinical investigation and evaluation.
- MDCG 2022-21 Guidance on periodic safety update report (PSUR) — Medical Device Coordination Group. Listed under post-market surveillance and vigilance.
- EUDAMED overview — European Commission.
Always check the consolidated text of the regulation and the current version of each guidance document before relying on it.
See it with your own device
Create an account, add your company and one real device. The Suite demo runs for 3 days and the first procedure opens straight away, not an empty dashboard.