EU Machinery Regulation 2027: the cutover and the technical file
On 20 January 2027 Regulation (EU) 2023/1230 replaces Directive 2006/42/EC for new placements, with no grandfathering. This page sets out the six things that changed, the three conformity routes, and what Annex IV actually asks for.
Last reviewed 2026-09-04 · MachineryReady, Harmony Future Holdings Limited, Dublin
What this page is
A plain-English reading of Regulation (EU) 2023/1230. It is free, and it is the same corpus our paid pack is built from. It is not legal advice and not a conformity assessment — it does not certify anything and it does not replace a notified body.
The date, and why there is no grace period
Machinery and related products placed on the market from 20 January 2027 must comply with Regulation (EU) 2023/1230 (Arts. 52, 54).
A file drawn up against the old Directive does not carry over
A technical file and declaration of conformity prepared only against Directive 2006/42/EC does not carry over for new placements after that date. Machines already on the market are not retrospectively caught — but everything you place from the cutover is on the new rules, whatever it was designed under.
The six changes
Cybersecurity and protection against corruption
New essential requirements: safety-related control systems and software must be protected against corruption, whether accidental or malicious. Evidence of hardware and software integrity belongs in the technical file (Annex III, 1.1.9 and 1.2.1).
In practice: This requirement did not exist under 2006/42/EC. It is where updated machines fail first.
Digital instructions
Instructions for use may be supplied digitally, provided they are accessible for the product’s lifetime and a paper copy is available free of charge on request at purchase, delivered within one month (Art. 10(7)).
In practice: The paper-on-request path has to exist and be logged.
AI and self-evolving safety functions
Machinery whose safety functions are ensured by systems with fully or partially self-evolving behaviour falls in Annex I Part A, requiring third-party conformity assessment (Annex I; Art. 25).
In practice: This can move a machine you self-certified onto a notified-body route.
Updated declaration of conformity
The EU declaration of conformity must reference Regulation (EU) 2023/1230 and follow Annex V.
In practice: Existing templates citing 2006/42/EC must be rewritten, not restamped. The references are what a surveillance authority reads first.
Risk assessment scope
The risk assessment must cover reasonably foreseeable misuse and, where relevant, the evolution of the machinery’s behaviour after placing on the market (Annex III, General principles).
In practice: An assessment covering intended use only is on the failure list.
Importer and distributor duties
Named obligations for importers and distributors, including verifying marking and documentation before making available (Arts. 13–15).
In practice: Non-EU manufacturers need the chain documented.
The three conformity routes
Article 25 puts a machine on one of three routes. The distinction that trips people up is Part B, which is neither plain self-assessment nor automatically third-party.
| Where the machine sits | Route | Basis |
|---|---|---|
| Outside Annex I | Internal production control (Module A). You compile the technical file, apply harmonised standards, and self-declare. | Art. 25(4) |
| Annex I Part B, and harmonised standards cover all the relevant essential requirements | Internal production control (Module A) is permitted. The standards coverage claim itself belongs in the technical file. | Art. 25(3) |
| Annex I Part B, without full standards coverage | A third-party procedure applies. | Art. 25(3) |
| Annex I Part A (including self-evolving safety functions) | Third-party conformity assessment is mandatory: EU type-examination plus conformity to type, full quality assurance, or unit verification. Harmonised standards alone do not remove the notified-body step. | Art. 25(2) |
We got this wrong once and fixed it
The first version of our own model was binary — Annex I or not — and it mis-routed Part B machinery to plain self-assessment. An adversarial corpus check in August 2026 caught it and added the third tier. We mention it because a binary model is the intuitive one, and if you built your own mental model the same way, it is worth re-checking your Part B machines.
If you need a notified body, the booking is the deadline
Notified-body capacity for the Regulation is finite and the cutover date is fixed. In practice the booking date, not the engineering, is what decides whether you make 20 January 2027.
- Identify a notified body designated for your machine category.
- Book the assessment slot now — capacity is the binding constraint, not your readiness.
- Prepare the technical file to Annex IV before the slot opens.
- Complete the assessment and obtain the certificate.
- Reference the notified body and certificate number in the Annex V declaration.
On the self-assessment route nobody external checks the file before the machine ships — which is exactly why the file’s completeness is the whole control:
- Confirm the machine really is outside Annex I, and record why.
- List the harmonised standards applied, by reference and version.
- Complete every Annex IV section in the file.
- Draw up the Annex V declaration under your sole responsibility.
- Affix the CE marking and retain the file for 10 years.
What Annex IV asks for
- General description of the machinery and its intended use.
- The risk assessment: hazards identified, requirements applied, protective measures adopted, residual risks.
- Design and manufacturing drawings and schemes needed to check conformity.
- Descriptions and explanations necessary to understand the drawings and the operation of the machinery.
- Evidence for safety-related software and, where relevant, protection against corruption (hardware and software integrity).
- Test reports and certificates: standards applied (listed with references), calculations, examinations.
- The instructions for use and, where applicable, the declaration of incorporation for partly completed machinery.
- The EU declaration of conformity (Annex V structure).
- For series manufacture: the internal measures ensuring the machinery remains in conformity.
The eight ways the file fails
- A technical file that exists but has never been assembled in one place. A market-surveillance request has a deadline, and ‘it is spread across three systems’ is not compliance.
- A declaration restamped from the 2006/42/EC template with only the date changed. The references are what a surveillance authority reads first.
- Harmonised standards listed without versions, so nobody can tell whether the version applied is the one that confers presumption of conformity.
- A risk assessment covering intended use only, with no treatment of reasonably foreseeable misuse.
- Safety-related software with no protection-against-corruption evidence. The requirement did not exist under 2006/42/EC, and it is where updated machines fail first.
- Digital-only instructions with no paper-on-request path, or a path that exists but is not logged.
- A notified body engaged too late, so a conforming machine cannot be placed on the market because the certificate is not yet issued.
- Partly completed machinery shipped with a declaration of conformity instead of a declaration of incorporation.
Penalties
Penalties are set by member-state law under the Regulation’s framework. The band applicable to a specific non-conformity is a legal determination and we do not assert it — the commercially decisive fact is simpler: a machine that cannot be placed on the market on 20 January 2027 is revenue you do not get, whatever the fine.
The technical file, ready for 2027
The free checker routes one machine. The pack takes your whole range: the Annex IV file skeleton, the delta report against 2006/42/EC, the gap list, and an Annex V declaration drafted for every machine.
Get the pack — €590