- Author
- MDRpilot Editorial Team
- Reviewer
- Independent regulatory review not yet assigned
- Last updated
- Applies to
- EU MDR 2017/745 Articles 83–88, Annex III, Annex XIV Part B
The PMS system
Article 83 requires a PMS system proportionate to the risk class and type of device, integrated into the QMS. It must actively and systematically gather, record and analyse data on quality, performance and safety throughout the lifetime of the device, draw conclusions and determine any preventive or corrective actions.
PMS report and PSUR
A PSUR summarises the results and conclusions of the PMS data analysis, the rationale for any preventive and corrective actions, the conclusions of the benefit-risk determination, the main findings of the PMCF evaluation report, sales volume and an estimate of the population using the device. MDCG 2022-21 gives guidance on content and format.
| Class | Document and frequency |
|---|---|
| Class I | PMS report (Article 85), updated when necessary and made available to the competent authority on request |
| Class IIa | PSUR (Article 86), updated when necessary and at least every two years |
| Class IIb | PSUR, updated at least annually |
| Class III and implantable | PSUR at least annually, submitted through EUDAMED to the notified body |
PMCF
Annex XIV Part B requires a PMCF plan describing the methods to proactively collect and evaluate clinical data, such as surveys of users, registries, literature review and PMCF studies. The results are analysed in a PMCF evaluation report, which feeds the CER and the risk management. MDCG 2020-7 and MDCG 2020-8 provide templates for the plan and the report. If PMCF is not considered necessary, the PMS plan must justify that.
Vigilance and trend reporting
Article 88 requires reporting of statistically significant increases in the frequency or severity of non-serious incidents or expected side effects, based on the thresholds defined in the PMS plan.
| Event | Reporting deadline (Article 87) |
|---|---|
| Serious incident | Immediately after establishing a causal relationship or its reasonable possibility, and not later than 15 days after awareness |
| Serious public health threat | Not later than 2 days after awareness |
| Death or unanticipated serious deterioration in health | Not later than 10 days after awareness |
Closing the loop
PMS is only useful when its outputs change something. Findings should update the risk management file (ISO 14971 clause 10), the clinical evaluation, the IFU where needed, and trigger CAPA when a nonconformity is found.
How MDRpilot supports PMS and PMCF
MDRpilot drafts the PMS plan and PMCF plan from the product record, provides a PMCF survey, sets the PSUR or PMS report outline by class and keeps complaints, vigilance, FSCA and CAPA records in the same workspace as the risk file and clinical evaluation. It does not submit reports to authorities or EUDAMED.
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.
This guide is general information about the regulation and standards named above. It is not legal or regulatory advice for a specific device.
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.