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MDR Technical File Index Generator

Check your Annex II and Annex III compliance. Generate a structured table of contents for your Notified Body submission.

Technical Documentation Checklist (Annex II & III)

Download a formatted .docx index ready for your technical file.

Ready for submission?

Alvento's agents can pre-audit your Technical File against Annex II/III requirements to ensure zero-deficiency submissions.

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Frequently asked questions

What's covered by Annex II and Annex III of EU MDR?
Annex II defines the technical documentation: device description, design and manufacturing information, general safety and performance requirements, risk-benefit analysis, V&V evidence and the PMS plan. Annex III covers post-market surveillance documentation. The generator maps every required section so nothing is missed.
Does it flag missing sections?
Yes. Incomplete or absent sections are flagged in the generated index, so you know exactly what is still owed before submission to your notified body.
What export formats are supported?
Markdown and DOCX. The Markdown output pastes cleanly into Confluence, Notion or any git-backed documentation system; the DOCX output integrates with Greenlight Guru, SharePoint and traditional QMS platforms.
Does this cover IVDR as well?
Not yet. The index follows EU MDR (Regulation 2017/745) only. An IVDR-specific (Regulation 2017/746) version is in development, contact us if you need early access.

Still have a question, or need a variant for your specific regulatory context? Ask us directly, or read our Insights for longer writeups.