Build technical files that hold up to 20 January 2027.
Machine Compliance is the workspace EU machinery manufacturers use to rebuild every technical file under Regulation (EU) 2023/1230 — risk assessment, harmonised standards, signed Declaration of Conformity, all in one place.
Built for regulatory affairs teams across Germany, France, and Italy. EU-hosted. GDPR-compliant. ISO 27001 in progress.
On 20 January 2027, every technical file built under Directive 2006/42/EC becomes legally invalid.
The rebuild itself is the harder part.
- Every active machine model in a separate Word document, with no shared structure across files
- Cybersecurity evidence under Annex III clauses 1.1.9 and 1.2.1 — a section your current files don't have
- Harmonised standards relisted under the new Regulation through 2026 and 2027, with no central place to track changes
- A Declaration of Conformity that puts your name on it, every time
The rebuild is a regulatory program, not a documentation task.
One workspace. Every file. Every machine. Every regulation.
Machine registry
One record per machine model, structured fields, version history, full audit trail from creation to retirement.
Risk assessment
Guided workflow built around the verbatim text of Annex III, in your language. Each hazard mapped to applicable harmonised standards.
Standards library
The full harmonised standards list under Regulation 2023/1230 and Directive 2006/42/EC, updated as the Commission publishes Implementing Decisions.
Signed Declaration of Conformity
Three-role signature workflow (editor, reviewer, signatory), cryptographic version snapshot at signature, regulator-ready audit log.
Built from Annex III, clause by clause.
Every screen references the Regulation directly. Every harmonised standard is linked to the OJ citation. Every signed Declaration of Conformity carries a version hash that proves the file has not been altered after signature.
Annex III — Essential health and safety requirements
Every section in your language, with guided workflow per clause.
Annex I Part A
High-risk machinery requiring Notified Body conformity assessment, flagged automatically in the registry.
CRA overlap
Cybersecurity evidence captured once, surfaced under both Machinery Regulation 2023/1230 (clauses 1.1.9, 1.2.1) and the Cyber Resilience Act 2024/2847.
AI Act overlap
AI safety functions flagged and documented under Regulation 2024/1689 alongside the Machinery file.
Your data sits in Frankfurt. Your files stay yours.
Machine Compliance operates under European law. Customer data is hosted in the EU and does not leave it. Files are not used to train AI models. Data is not shared with third parties.
EU-hosted infrastructure
AWS Frankfurt region, EU-region Postgres, no data transfer outside the EU.
GDPR-compliant by design
Full data export at any time, full deletion within 30 days of request, data processing agreement included with every paid plan.
ISO 27001 certification
In progress, target completion Q3 2026.
No AI training on customer data
AI-assisted drafts are processed under a zero-retention agreement. Data is deleted on completion of each request.
Verifiable audit trail
Every Declaration of Conformity signature includes a SHA-256 hash of the full file state. File integrity can be verified to a regulator independently of Machine Compliance.
From signup to signed Declaration of Conformity in 30 days.
- Day 1
Create your company workspace and import your first machine. CSV import from existing Excel, or start from scratch.
- Day 1–14
Walk through the risk assessment for your first machine. Annex III, clause by clause, in your language. Pick applicable harmonised standards from the live library.
- Day 14–28
Generate the technical file PDF. Review with your team. Iterate.
- Day 28–30
Signatory signs the Declaration of Conformity. The version is locked. The audit trail is written.
Built for the regulatory affairs teams that ship machines into the EU.
Most customers fall into one of three profiles:
Mid-market machine manufacturer
One regulatory affairs lead, 5–30 active machine models, currently working in Word and Excel.
Industrial system integrator
Newly in scope under the substantial modification rule of Regulation 2023/1230, inheriting manufacturer obligations for the first time.
CE marking consultancy
Billing clients for technical files. The consultancy plan supports white-label outputs and manages every client engagement from one workspace.
Pricing
Annual billing. No setup fees.
Solo
€349/month
Team
€799/month
Business
€1,499/month
Larger teams or 100+ machines?