Module8 April 20264 min read
Module spotlight: PMCF & PSUR
Post-market clinical follow-up and periodic safety reporting are how a device keeps proving itself after launch. These modules keep that ongoing evidence structured.
By MoniDoseQMS Team
Clinical evidence does not end at approval. Post-market clinical follow-up (PMCF) keeps gathering real-world data, and the periodic safety update report (PSUR) summarises the safety picture at regular intervals. Together they keep your device's benefit-risk balance current.
What you can do
- Build PMCF plans, reports, and evaluation reports
- Produce PSUR reports and evaluations on schedule
- Connect post-market evidence to clinical evaluation and risk
- Keep a continuous, traceable clinical record after launch
Why it matters
EU MDR makes PMCF and PSUR continuing obligations (Articles 83-86 and Annex XIV Part B). Keeping them inside the QMS means post-market findings flow straight back into the clinical evaluation and risk files they should update.