Postmarket Surveillance
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Postmarket surveillance is the proactive, systematic process a device manufacturer runs to collect and analyze real-world experience with a device already on the market — complaints, service data, literature, and registry information — to identify emerging safety signals and quality trends and to update the risk-benefit assessment before a serious incident forces a reactive response.
Under EU MDR, postmarket surveillance is a formal, documented system with a PMS plan proportionate to the device’s risk class, feeding a Post-Market Surveillance Report (lower-risk devices) or a Periodic Safety Update Report (higher-risk devices, updated regularly and reviewed by the Notified Body for Class III/implantable devices). In the US, postmarket surveillance overlaps with, but is broader than, the mandatory Medical Device Reporting system — it also covers voluntary complaint trending, literature surveillance, and FDA-ordered postmarket surveillance studies for select higher-risk devices.
Postmarket surveillance findings feed back into the risk management file, and a signal strong enough to change the risk-benefit conclusion can trigger a Field Safety Corrective Action or, under MDR, a vigilance report — the postmarket system is the sensor, vigilance reporting is the alarm.
- —Proactive, systematic collection and analysis of real-world device experience
- —EU MDR requires a PMS plan feeding a PSUR (higher-risk) or PMS report (lower-risk)
- —21 CFR Part 822 covers FDA-ordered postmarket surveillance studies for select devices
- —Feeds back into the device’s risk management file and can trigger vigilance reporting
EU MDR 2017/745 Articles 83–86 and Annex III; 21 CFR Part 822 (postmarket surveillance studies); 21 CFR Part 803 (Medical Device Reporting)
Frequently asked questions
What is Postmarket Surveillance?
Postmarket surveillance is the proactive, systematic process a device manufacturer runs to collect and analyze real-world experience with a device already on the market — complaints, service data, literature, and registry information — to identify emerging safety signals and quality trends and to update the risk-benefit assessment before a serious incident forces a reactive response.
Which regulations cover Postmarket Surveillance?
EU MDR 2017/745 Articles 83–86 and Annex III; 21 CFR Part 822 (postmarket surveillance studies); 21 CFR Part 803 (Medical Device Reporting)