Post-Market Surveillance (PMS)
Post-Market Surveillance (PMS) refers to the systematic and proactive process of collecting, recording, and analysing experience data on medical devices already available on the market. Under EU MDR Articles 83–86, manufacturers must establish a PMS system covering vigilance reports, customer feedback, post-market clinical follow-up data (PMCF), and trend analyses. The results feed into the PMS report or the Periodic Safety Update Report (PSUR) and may trigger updates to the risk analysis, technical documentation, and instructions for use.
In the IFU translation process, PMS has a direct impact: safety-relevant findings may necessitate short-notice changes to the instructions for use that must then be implemented across all language versions simultaneously. The risk class of the product determines the frequency and scope of PMS reporting.
Frequently Asked Questions
Why does post-market surveillance also affect IFU translation?+
Findings from market surveillance – such as user feedback, vigilance reports, or corrective actions – may require changes to the instructions for use. Every update to the source text must be promptly reflected in all affected language versions to maintain regulatory compliance across all target markets. Efficient translation management with translation memory systems ensures that only modified sections need to be re-translated.