The structure
The structure: Annex II and III section by section — description, design, GSPR, V&V, CER, PMS.
Free field guide · PDF
EU MDR Technical Documentation2026 Field Guide
The structure, the GSPR matrix, and the practice — with the documentation work you need.
- Tech file
- Annex II
- PMS docs
- Annex III
- Matrix
- GSPR
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The GSPR matrix
The GSPR matrix: every requirement mapped to objective evidence — the spine of the file.
The practice
The practice: the living-document discipline, the completeness review, and the failure modes.
Sources & scope
- celegence.com, EU MDR Checklist: Technical Documentation Requirements for Medical Device Manufacturers.
- nabila0721/claude-skills, mdr-745-specialist skill (github.com).
- thomasmoreai/legal-skills-open, mdr-745-specialist skill (github.com).
This guide is market-access intelligence, not regulatory or legal advice. MDR technical documentation requirements and notified-body practice change — professional review is required before business use.
Market Access Strategy Session
Technical file on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your documentation route — Annex II/III structure, GSPR matrix build, and NB readiness.
Professional review is required before business use.
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