TemplatesEU

EU Machinery Regulation (EU) 2023/1230 Templates

Reusable artifacts for route decisions and CE evidence packs.

Copy/paste these into your technical file system and keep them versioned.

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Author

Sorena AI

Published

Feb 21, 2026

Updated

Feb 21, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published Feb 21, 2026

Updated Feb 21, 2026

Overview

These templates reflect what reviewers actually look for: a defensible route decision, a risk assessment-to-EHSR map, and an exportable Annex IV technical file index. Use them per product family and link every field to evidence locations and versions.

Section 1

1) Scope memo template (Article 2 + product type)

Purpose: a one-page, defensible scope decision per product family.

Product ID: model(s), variants, intended use, environment, operators/exposed persons.
Product type: machinery / related product (which one) / partly completed machinery / safety component (incl. software).
Exclusions checklist (Article 2(2)): list each relevant exclusion and mark 'not applicable' with rationale.
Electrical products exclusion check: confirm whether the product is excluded insofar as it falls under LVD/RED categories.
Applicable legislation list: include other EU acts if incorporated products require them (for DoC/DoI statements).

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Section 2

2) Annex I classification note (Part A / Part B / not listed)

Purpose: a precise category match that drives the Article 25 route.

Annex I match: exact item number and sub-item where applicable.
Rationale: product facts that match the category definition.
Boundary: which parts/systems are covered by the category match (especially for embedded systems).
Decision: Part A / Part B / not listed; link to route memo.

Section 3

3) Article 25 route decision memo template

Purpose: a route decision that is stable and reviewable (and defines change triggers).

Selected procedure: Article 25(2) (B+C / H / G) or Article 25(3) or 25(4) (Module A).
If Part B + Module A: evidence that harmonised standards/common specs for that category cover all relevant EHSR and are applied.
Notified body involvement plan (if applicable): scope, schedule, evidence readiness date, change control triggers.
CE marking implications: include notified body identification number when required.
Outputs: technical file index + declarations + release gate checklist.

Section 4

4) Annex III risk assessment and EHSR mapping table (EHSR -> measures -> evidence)

Purpose: a single mapping table that connects the safety case to evidence artifacts.

EHSR (Annex III) | Hazard/hazardous situation | Protective measure | Verification method | Evidence ID | Residual risk + instruction reference
Include lifecycle phases and foreseeable misuse assumptions in the header.
Include autonomy/self-evolving behavior and system interaction hazards where relevant.

Section 5

5) Annex IV technical file index template (Part A/B)

Purpose: an exportable index that makes the file reviewable in minutes.

00-Index/: scope memo, Annex I note, route memo, index.pdf/json
01-Risk/: hazard log, EHSR mapping table, residual risks register
02-Design/: drawings, schematics, safety functions description
03-Standards/: standards/common specs register, clause mapping, update log
04-Verification/: test plan, test reports, inspections, calculations
05-Production/: series conformity controls
06-Instructions/: instructions for use, translations; assembly instructions if partly completed
07-Declarations/: DoC/DoI, history, signatory evidence
08-Software-Control/: software inventory, intervention logs, validation summaries (as applicable)

Section 6

6) EU Declaration of Conformity (DoC) skeleton

Purpose: a DoC that matches the route, evidence pack, and any incorporated-product obligations.

Product identification; manufacturer details; authorised representative (if any).
Statement of sole responsibility.
Applicable Union harmonisation legislation: include Regulation (EU) 2023/1230 and any other applicable acts for incorporated products (where relevant).
Standards/common specifications references (with versions).
If notified body involved: include certificate references and ensure CE marking number handling is consistent.
Signatory details (name, function, place/date, signature).

Section 7

7) Partly completed machinery pack: Declaration of Incorporation + assembly instructions checklist

Purpose: a coherent pack for incorporation customers and for authority requests.

Declaration of Incorporation (DoI) issued and kept updated; translated as required.
Assembly instructions provided and aligned to residual risks and incorporation conditions.
Digital provision policy defined where used: users must be able to print/download and access during breakdowns; online accessibility period tracked where applicable.
Annex IV Part B technical documentation index complete.

Section 8

8) Notified body assessment pack outline (for Annex I routes)

Purpose: reduce notified body cycle time with a clean evidence narrative.

Route memo + Annex I classification + system boundaries.
EHSR mapping summary and key protective measures narrative.
Key verification evidence set (representative tests, inspections, calculations).
Change history and configuration control (software versions, safety functions versions).

Primary sources