Understand PMS reports and PSURs
Know why the reporting route depends on device type and classification.
Complya does not generate a PMS report or PSUR from live surveillance data. It can hold source material and reviewed documents, while the manufacturer remains responsible for the underlying data and process.
Post-market reporting requirements depend on the device, regulation, class, and applicable route. Some devices require PMS reports; higher-risk devices may require periodic safety update reporting.
The assigned expert can review the applicable route and the evidence supplied for the case; that review does not replace the manufacturer's surveillance obligations.
Keep report inputs current: complaints, incidents, trend analysis, sales volume, benefit-risk conclusions, CAPA links, PMCF results, and any changes to clinical or risk conclusions.
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.
European Commission — Medical Devices: New regulationsRegulation (EU) 2017/745 — Medical Device RegulationRegulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices