Q1. What is post-market surveillance under MDR?
It is an ongoing, systematic process of collecting and analyzing real-world device safety and performance data, then using that information to update risk management, clinical evaluation, and technical documentation.
Q2. What is a PMS plan?
A PMS plan is the documented description of how a manufacturer will collect, record, analyze, and act on post-market data for a specific device, including vigilance, post-market clinical follow-up, and feedback sources.
Q3. What are PSURs for medical devices?
Periodic Safety Update Reports (PSURs) are mandatory for non-class I devices. Over a defined period of time, they must summarize:
- PMS findings,
- benefit-risk evaluation,
- sales data, and
- CAPA or FSCA
Q4. How does CAPA fit into PMS?
PMS and vigilance feed signals into corrective and preventive action systems, which define, implement, and verify corrective or preventive actions. This integration shows regulators that safety issues are actively managed.
Q5. Is PMS required for legacy and low‑risk devices?
Yes. MDR requires a PMS system and plan for all devices placed on the EU market, including legacy and class I devices, with the level of detail scaled to the device’s risk.
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