mdr-tech-file-gen

YAML device spec → CE-MDR Annex II/III technical file scaffolding in one command. Pure-Python CLI that reads a typed device.yaml, validates it against a Pydantic schema, and renders an Annex II/III technical-file skeleton — an engineering team starting point for MDR Annex II/III scaffolding, NOT a finished submission. Most evidence sections ship as [TODO] placeholders the manufacturer must complete.

# v0.1: install from source (PyPI release pending)
pip install git+https://github.com/plusultra-tools/mdr-tech-file-gen.git
mdr-techfile scaffold --spec device.yaml --out techfile/

Why this exists

Solo-founder med-device / SaMD startups in the EU have three options for assembling the Annex II/III technical file Regulation (EU) 2017/745 demands:

1. Hire a regulatory consultant — €5,000–€15,000 for the first draft, plus retainer. Outside the budget when you're still pre-revenue.
2. Buy a template pack — Advisera sells one for €700+. OpenRegulatory gives away Word/Markdown templates for free, no strings attached, and is the de-facto reference for the bootstrapped end of the market.
3. Write it from scratch — six weeks of regex-and-Google before a Notified Body will look at you.

mdr-tech-file-gen is the structured / CI-friendly upgrade to option 2. OpenRegulatory templates are excellent prose, but they are static Word docs — you can't diff them in code review, you can't generate them from a single source of truth, you can't fail a pipeline when a required section is missing, and you can't reference them from issue trackers.

This tool takes a single device.yaml (intended use, risk class, IEC 62304 software safety class, SOUP register, intended users, clinical claims) and renders Annex II + Annex III scaffolding as Markdown plus a manifest.json that MDR-cross-references each generated section to the relevant Annex II/III paragraphs and ISO/IEC standards (verbatim EUR-Lex clause text is on the roadmap — v0.2). You commit the YAML and the generated skeleton to git, you iterate the YAML, you regenerate. The manufacturer fills in the substantive evidence; the tool keeps the structure honest.

What it does

1. pip install git+https://github.com/plusultra-tools/mdr-tech-file-gen.git — pure Python, no Java, no MS Word. (PyPI release pending.)
2. mdr-techfile scaffold --spec device.yaml --out techfile/ — renders Annex II + Annex III Markdown skeletons + a standards-matrix.md + a checklist.md + a manifest.json + an audit.sha256 chain.
3. mdr-techfile validate --spec device.yaml — checks the YAML against the Pydantic schema. Exits 0 if valid, 1 with a structured error list if not. Designed for CI.
4. mdr-techfile manifest --spec device.yaml — dumps the citation pointer mapping (each generated section → MDR Annex II/III paragraphs + ISO 14971/IEC 62304/IEC 62366 standard clauses), so a reviewer can audit which clauses each section is meant to address. Note: pointers are citation metadata; verbatim EUR-Lex clause text is roadmap (v0.2).

What gets generated

scaffold writes 3 Jinja2-rendered Markdown files plus a checklist, a JSON manifest, and an audit hash chain:

• annex-II.md — Annex II technical-documentation skeleton with the following headings inside one document, aligned with MDR Annex II (technical documentation):
  1. Device description and specification — Annex II §1.1
  2. Reference to previous and similar generations of the device — Annex II §1.2
  3. Information to be supplied by the manufacturer (labelling, IFU, UDI) — Annex II §2
  4. Design and manufacturing information — Annex II §3
  5. General safety and performance requirements (GSPR) — Annex II §4, Annex I (static placeholder table in v0.1; spec→GSPR mapping is roadmap v0.3)
  6. Benefit-risk analysis and risk management file — Annex II §5, ISO 14971:2019
  7. Software lifecycle file (SaMD only) — IEC 62304:2006+A1:2015, MDCG 2019-11, MDCG 2019-16
  8. Usability engineering file — IEC 62366-1:2015+A1:2020
  9. Biological and clinical safety / materials — ISO 10993 series
  10. Product verification and validation — Annex II §6
  11. Clinical evaluation — Annex II §6.1, MDR Article 61, MDCG 2020-6, MDCG 2020-13
• annex-III.md — Annex III post-market surveillance skeleton (post-market surveillance plan, PMCF plan, Declaration of Conformity pointers) — Annex III, MDR Articles 83–86, Annex XIV Part B, Annex IV.
• standards-matrix.md — table mapping each section to the ISO/IEC standards it cites.
• checklist.md — structural completeness checklist derived from the spec.
• manifest.json — machine-readable citation pointer manifest.
• audit.sha256 — SHA-256 chain of all generated files for tamper-evidence.

Each section currently ships with a citation pointer to the MDR clause + ISO/IEC standard it addresses. Verbatim EUR-Lex clause text is on the roadmap (v0.2). Most evidence rows ship as [TODO] — this is a scaffold, not a finished file.

What it does NOT do

• NOT a regulatory consultant. It generates structure and citations. It does not write your clinical evaluation. It does not assess your risk file.
• NOT legal advice. Use of this tool does not establish a regulatory affairs relationship. The output is a starting skeleton; a competent regulatory professional must review the completed file before submission.
• NOT a substitute for Notified Body conformity assessment. For Class IIa, IIb, III devices, a Notified Body assessment is mandatory under MDR. This tool helps you prepare the documentation the NB will audit; it does not replace the audit.
• NOT QMS software. It does not implement ISO 13485 quality management processes. Plug it into your existing QMS (Greenlight Guru, Matrix, Qualio, Notion + git, whatever).
• NOT MDR-certified itself. The tool is not a medical device. It is a documentation scaffolder.

Pricing

• CLI: MIT licensed, free forever. Source on GitHub.
• A hosted CI integration is on the roadmap (pricing TBD pending demand validation). No paid tier is shipped today.

Comparison to adjacent tooling

• OpenRegulatory templates — excellent free Word/Markdown prose templates, community-edited, very respected in the bootstrapped MDR space. mdr-tech-file-gen is the schema-driven / git-native sibling: same target audience, different ergonomics. We cite OpenRegulatory in our docs and recommend reading their templates alongside the generated skeleton.
• Advisera 13485 toolkit — €700+ for a polished pack with consulting hours bolted on. Better fit when you already have a budget; ours is the no-budget path.
• Matrix Requirements / Greenlight Guru / Qualio — full eQMS platforms, €2K–€20K/year, way past where most solo founders start. Complementary later; competitive too early.

Roadmap

• v0.1 (this release) — Pydantic spec schema, 3 Jinja2 templates (annex-II, annex-III, standards-matrix), scaffold / validate / manifest CLI, fixture device YAML, smoke-test in CI. PyPI release pending.
• v0.2 — Verbatim MDR Annex II + III clause text from EUR-Lex Regulation (EU) 2017/745 (today citations are pointer metadata only, NOT verbatim clause text). --format docx exporter for Notified Body submission.
• v0.3 — GSPR checklist generator: real spec→Annex I §1–§23 applicability mapping (today the GSPR table is a static placeholder). ISO 14971 risk-table template with structured hazard/harm/control rows. SOUP register CSV emitter.
• v0.4 — Hosted CI validator MVP. Pricing to be determined after demand validation.
• v1.0 — Wire-format stability for the manifest schema; semver guarantees.

Audience

• Class I / IIa solo-founder med-device and SaMD startups in the EU.
• Bootstrapped digital-health teams shipping under MDR who can't justify €5K+ consultant fees pre-revenue.
• Regulatory-conscious open-source health-tech projects that want their documentation in git, not in a Word doc on someone's laptop.
• Distribution channels: r/medicaldevices, r/IndieBiotech, r/SaaS, Hacker News (Show HN), awesome-mdr GitHub lists, the OpenRegulatory community Slack, LinkedIn regulatory-affairs groups.

Contributing

Open an issue with a real device.yaml that fails to scaffold, or a section that doesn't map cleanly to your device class. PRs welcome — especially for additional standard references (ISO 13485:2016, ISO 14155:2020, ISO 27001 for SaMD security) and template polish.

License

MIT. See LICENSE.

Disclaimer

This tool is provided as-is. It does not constitute regulatory or legal advice. Compliance with Regulation (EU) 2017/745 (MDR) and the harmonised standards remains the sole responsibility of the device manufacturer.