EU MDR · Medium · 13 min lesson
PMCF, serious incident reporting, field safety corrective actions and timelines
EU MDR 2017/745 Articles 87 and 89, Annex XIV Part B, Annex III, MDCG 2020-7, MDCG 2023-3
What you will learn
- Explain PMCF under Annex XIV Part B, the minimum content of the PMCF plan and how the evaluation report feeds the clinical evaluation.
- Classify an event as a reportable serious incident and apply the Article 87 periods of 2, 10 and 15 days from awareness.
- Run an Article 89 investigation, report an FSCA before action and write a field safety notice that meets Article 89(8).
Key takeaways
- PMCF is continuous and proactive: a plan under Annex XIV Part B point 6 and an evaluation report under points 7 and 8.
- Serious incidents are reported immediately and within 15 days of awareness; 10 days for death or unanticipated serious deterioration; 2 days for a serious public health threat.
- Initial incomplete reports are allowed (Article 87(6)); uncertainty does not postpone reporting (Article 87(7)).
- Do not alter the device before informing the authority; report an FSCA before carrying it out (Articles 89(1), 87(8)).
- The field safety notice names devices with UDI, explains risks honestly and lists user actions (Article 89(8)).
Free practice question
On 4 March an Aerovance field engineer learns that a patient on a home ventilator died after a battery alarm and failure. The email reaches the complaint handler on 11 March, who opens the case. A death is suspected and a link is reasonably possible.
By what date must the report be filed, and what is the process gap?
Due 21 March, counted from entry in the system; no gap.
Not quite. Article 87 runs from awareness, not from the date a complaint was entered in the system, so this date is too late.
Due 14 March, counted from 4 March awareness; the gap is that field staff information was not routed immediately.
Correct. Article 87(5) gives ten days from awareness for a death, and the engineer's receipt on 4 March is the conservative start.
Due 19 March, using the 15 day period.
Not quite. Fifteen days applies under Article 87(3) to other serious incidents, while a death falls under the ten day period.
Due 6 March, using the 2 day period.
Not quite. Two days under Article 87(4) is for a serious public health threat, which a single death does not automatically constitute.
Key terms
- PMCF: Continuous, proactive collection and evaluation of clinical data from a CE-marked device in use (Annex XIV Part B).
- PMCF evaluation report: Report analysing PMCF findings, part of the clinical evaluation report and technical documentation (Annex XIV Part B point 7).
- 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).
- awareness: The point from which the Article 87 periods run; the guidance MDCG 2023-3 explains how to determine it.
- serious public health threat: An event that could result in imminent risk of death or serious deterioration for many people; reported within 2 days (Article 87(4)).
- FSCA: A corrective action for technical or medical reasons to prevent or reduce the risk of a serious incident (Article 2).
- FSN: The notice sent to users about an FSCA, with content set in Article 89(8).
- final report: The manufacturer's report of findings, conclusions and corrective actions after an investigation (Article 89(5)).
Official sources
- MDR Article 87 - Reporting of serious incidents and field safety corrective actions
- MDR Article 89 - Analysis of serious incidents and field safety corrective actions
- MDR Annex XIV - Clinical evaluation and post-market clinical follow-up
- MDCG 2023-3 Rev.2 Questions and Answers on vigilance terms and concepts
- MDCG 2020-7 Guidance on PMCF plan template
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.