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MDR PSUR Outline Generator

Generate a periodic safety update report outline for EU MDR Article 86 compliance. Tailored to your device class.

Device Information
Reporting Period

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Frequently asked questions

What is a PSUR under EU MDR?
A Periodic Safety Update Report, mandated by Article 86 of Regulation (EU) 2017/745 for Class IIa, IIb and III devices. It summarises post-market surveillance findings, benefit–risk conclusions, incident data and any corrective or field-safety actions taken in the reporting period.
How often is a PSUR due?
Class IIa: at least every two years. Class IIb and III: annually, and whenever necessary. Implantable and Class III devices also require submission to the notified body and EUDAMED.
Does this tool replace a QMS?
No. It produces a conformant Article 86 outline to anchor your drafting. You still need a live PMS plan, PMCF data where applicable, PRRC sign-off, and routing through your quality management system before release.
Can the output go straight into my technical file?
Treat the outline as a starting scaffold. Populate each section with your PMS outputs, incident register extracts and trend analyses, then review under your QMS document-control process before issuing.

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