ISO 13485 · Expert · 15 min lesson
Auditing PMS, PMCF, PSUR and vigilance (MDR Articles 83 to 92)
EU MDR 2017/745 Articles 83 to 92, Annex III and Annex XIV Part B; MDCG 2022-21; ISO 19011 audit practice
What you will learn
- Audit the PMS plan and PMS report.
- Audit PMCF plan and evaluation.
- Audit serious incident reporting and field safety corrective actions.
Key takeaways
- The PMS plan (Article 84, Annex III) needs indicators, thresholds, a trend method and a PMCF plan or justification.
- Report cadence follows class: PMS report for class I (Article 85), PSUR at least every two years for IIa, annually for IIb and III (Article 86).
- PMCF (Annex XIV Part B) must be planned, running, evaluated and fed into the clinical evaluation and PSUR.
- Article 87 limits run from awareness: 15 days generally, 10 days for death or unanticipated serious deterioration, 2 days for a serious public health threat.
- A field safety corrective action file shows investigation, risk assessment, notice, recipients and a check that the action worked (Article 89).
Free practice question
Halden's class IIa feeding set has a PSUR dated 18 months ago. The PMS plan states 'PSUR every two years'. The auditor visits at month 20.
What is the correct conclusion?
No nonconformity on cadence: class IIa requires an update when necessary and at least every two years, and the next one is not yet due.
Correct. Article 86 sets a minimum of every two years for class IIa, so month 20 is still within the cycle.
A Major finding, because all PSURs must be annual.
Not quite. Annual updates are required for class IIb and III under Article 86, not for class IIa.
A finding against Article 85, because the report is overdue.
Not quite. Article 85 is the report for class I devices, and the class IIa report is not overdue under Article 86.
A finding because the plan should not fix a cadence.
Not quite. Annex III expects the plan to be clear about reporting, so stating a cadence is good practice.
Key terms
- PMS plan: The device specific plan for collecting and assessing post market data, part of the technical documentation (Article 84, Annex III).
- PSUR: The periodic report for classes IIa, IIb and III summarising PMS conclusions and benefit-risk (Article 86).
- PMS report: The summary report for class I devices, updated when necessary (Article 85).
- PMCF: A continuous process proactively collecting clinical data on a device in use (Annex XIV Part B).
- serious incident: An incident that led, might have led or might lead to death, serious deterioration of health or a serious public health threat (Article 2).
- FSCA: A corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce risk of serious incidents.
- field safety notice: The communication sent to users about an FSCA without delay (Article 89).
- trend reporting: Reporting a statistically significant increase in non serious incidents or expected side effects (Article 88).
Official sources
- Regulation (EU) 2017/745 on medical devices (MDR), EUR-Lex
- MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745
- MDCG 2020-8 Guidance on PMCF evaluation report template
- MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.