Placing a device on the market triggers a set of structured, ongoing obligations under Articles 83-86 and Annex III of Regulation (EU) 2017/745. Manufacturers are required to proactively collect, evaluate, and act on real-world device performance data, not as a one-time exercise, but continuously across the device’s commercial lifetime.
The Post-Market Surveillance template provides a unified framework covering the PMS System, PMS Plan, PMS Report, PSUR, and FSCA, each addressing a distinct aspect of the manufacturer’s ongoing surveillance obligations.
The PMS System establishes the overall surveillance infrastructure. The PMS Plan defines how data is collected, monitored, and reviewed. The PMS Report captures surveillance findings and CAPA outcomes for Class I devices. The PSUR delivers a periodic safety and benefit-risk evaluation for higher-risk devices. The FSCA addresses corrective actions taken in the field where required. All documents are aligned with MDCG 2022-21, MDCG 2025-10, MEDDEV 2.12-1 Rev. 8, and ISO/TR 20416.
This template, developed by experienced regulatory professionals, ensures every post-market obligation is covered, documented, and defensible in line with the current state of the art.
Price: $1600 $1280 (20% off)
