MDR Art. 83–86 · PSUR · PMCFIn development
Post-Market Surveillance
The living half of the file: PMS data intake, PSUR cadence and PMCF activity tracking on the same governed record.
IN THE PLATFORM TODAY
The PMS Plan, PSUR and PMCF Plan are drafted in the technical file today, and after launch the reporting periods are scheduled and tracked on the case. Intake of the surveillance data itself, and drafting from it, are in development.
What the dedicated workflow will add
In development. Planned scope, honestly labelled.
PMS data intake against the plan's defined sources.
PSUR drafting on the Article 86 cadence, from the recorded data.
PMCF activity tracking with evidence flowing back into the clinical record.