Post-market monitoring: the Art. 72 plan and the monitoring cycle
After deployment the work continues: a monitoring plan per high-risk system, recurring reviews on the calendar, and the paper trail that connects field experience back into risk management.
Operations → Post-Market Monitoring tracks Article 72: providers of high-risk systems must run a documented post-market monitoring system — actively collecting how the system behaves in the field and feeding that back into risk management, for the lifetime of the system.
This is the Monitor phase of the six-phase compliance journey — the phase that never completes, by design.
The monitoring plan
Each high-risk system carries monitoring-plan obligations: what data you collect (performance metrics, drift signals, user feedback, complaints), how often you review it, thresholds that trigger action, and who is responsible. Work them on the system's Post-market tab like any obligation — checklist, fields, evidence, owner. The plan itself belongs in your Annex IV technical documentation; the generator pre-fills it from what you record here.
The recurring cycle
Monitoring is a cadence, not a document. Veritome keeps it moving:
- Review schedules put the recurring monitoring review on the Calendar, with reminders to the owner.
- Completing a review records who and when, auto-creates the next occurrence, and drops a dated entry into the system's regulator dossier — so the chain of custody shows monitoring actually happened, review after review.
- Findings that need action become risk register items or, when serious enough, incidents.
Where incidents fit
A serious incident (Art. 73) is the sharp end of post-market monitoring — the 15-day statutory clocks and authority reporting are covered in Incident reporting. This workspace is the routine that makes those rare; the two share the same field data.