MDR Technical File Index Generator
Map the Annex II and Annex III documents you have into an index. This checklist does not assess document quality or establish compliance. Review the output with a qualified specialist before use.
Technical Documentation Checklist (Annex II & III)
Download a Word-ready .doc index for your technical file.
Organise your technical documentation
Alvento can help organise your technical documentation and check which sections have been supplied. Specialist assessment of the documents and applicable requirements is agreed separately.
Discuss your documentation workflowFrequently 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 tool provides a starting index for review; it does not verify that all applicable requirements are covered.
Does it flag missing sections?
Yes. Incomplete or absent sections are flagged in the generated index, based on your selections. This is not an assessment of the documents themselves.
What export formats are supported?
Markdown and a Word-ready .doc file (HTML format). The Markdown output pastes cleanly into Confluence, Notion or any git-backed documentation system; the .doc file opens directly in Microsoft Word and can be reviewed and saved in your document-control workflow.
Does this cover IVDR as well?
Not yet. The index follows EU MDR (Regulation 2017/745) only. If you need an IVDR (Regulation 2017/746) version, contact us and tell us what you need.
Still have a question, or need a variant for your specific regulatory context? Ask us directly, or read our Insights for longer writeups.