MDR PSUR Outline Generator
Generate a periodic safety update report outline for review against EU MDR Article 86. Tailored to your device class.
Device Information
Reporting Period
Explore a drafting concept
The full PSUR Draft Generator is an unbuilt concept. It proposes draft preparation from source material; those capabilities are not available. The free outline tool on this page is separate.
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Alvento can help scope document-preparation workflows. Independent regulatory specialists can be included depending on requirements, availability and cost. Workflow assistance is separate from specialist assessment and formal certification.
Discuss document preparationFrequently 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 draft 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.
Still have a question, or need a variant for your specific regulatory context? Ask us directly, or read our Insights for longer writeups.