Compliance
PMS
Post-Market Surveillance · post-market surveillance · pmcf
TL;DR
Active, systematic collection of device performance & safety data after market release — required under MDR/IVDR (mandatory PSUR for higher classes) and FDA 803/806/822.
Post-Market Surveillance is the lifelong obligation to collect, analyse and act on data from devices in the field — complaints, MDRs, literature, registries, user feedback, post-market clinical follow-up. Under MDR/IVDR, the PMS plan and Periodic Safety Update Report (PSUR) are mandatory deliverables. Findings feed back into risk management and CAPA.
V5's complaints + MDR module captures field events, triages to investigation, ties to CAPA, and assembles PSUR-ready trending.
Regulatory anchors
- Regulation (EU) 2017/745 Art. 83-86
- 21 CFR 803
- 21 CFR 806
- 21 CFR 822