Machinery Regulation 2027: checklist for non-EU makers
10 min readRepresenta GmbH
Machinery Regulation 2027: what applies from 20 January 2027, which units still fall under the old Directive, and a seven-step checklist for non-EU makers.
Regulation (EU) 2023/1230 applies from 20 January 2027 and replaces the Machinery Directive 2006/42/EC. For manufacturers outside the EU, the question is not the model but each unit: which machines still fall under the Directive, and what must be ready for the rest? This guide to the Machinery Regulation 2027 ends with a seven-step checklist.
Machinery Regulation 2027: what replaces the Directive, and when
Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC and applies directly in every member state (Article 54). The Directive is repealed with effect from 20 January 2027 (Article 51(2)).
Watch the date: the text published in June 2023 said 14 January 2027. A corrigendum (opens in a new tab)) (OJ L 169, 4 July 2023) replaced it with 20 January 2027.
| Topic | Directive 2006/42/EC | Regulation (EU) 2023/1230 |
|---|---|---|
| Instructions for use | Accompany the machine (Annex I, 1.7.4) | Digital allowed under conditions (Art. 10(7)) |
| Declaration of Conformity | Accompanies the machine; names an EU person authorized to compile the technical file | Link or code possible; names manufacturer and, where applicable, representative (Art. 10(8), Annex V) |
| Authorized Representative | May carry out the manufacturer's steps (Art. 5(1)) | Design and technical file excluded (Art. 12(1)) |
| Higher-risk machines | Annex IV; internal checks possible with harmonized standards | Annex I, Part A always with a notified body |
| New topics | Not covered | Substantial modification, cyber protection, self-evolving behaviour |
Before or after 20 January 2027: which rules apply to which unit
There is no sell-off period for new units. Article 52(1) protects only machines placed on the market in conformity with the Directive before 20 January 2027; dealers may keep selling that stock. Every unit placed on the market from that date must meet the Regulation, even if the model has been sold for years (Blue Guide, section 2.3).
The Blue Guide's examples show which date counts (section 2.12): for an EU importer, the release for free circulation; for a finished machine sold directly to an EU customer, the accepted order, even if customs see it later.
According to the Commission, a declaration issued before the cut-off may also state conformity with the Regulation where applicable, naming both acts with their periods (Blue Guide, section 2.11). EC type-examination certificates remain valid until they expire (Article 52(2)); clarify their scope with your notified body.
Annex I, AI and cyber protection: the new conformity questions
Two topics need engineering work, not just paperwork.
When a notified body is mandatory
- Not in Annex I: internal production control (module A), no notified body (Article 25(4)).
- Annex I, Part B (19 categories, such as circular saws and presses): module A only with harmonized standards or common specifications covering all relevant requirements, otherwise a notified body (Article 25(3)).
- Annex I, Part A (6 categories): always a notified body (Article 25(2)).
Four categories that allowed internal checks with harmonized standards under the Directive move to Part A: removable mechanical transmission devices, their guards, vehicle servicing lifts and portable cartridge-operated fixing and other impact machinery (points 1 to 4). New are safety components, and embedded systems in machines, with self-evolving behaviour using machine learning that ensure safety functions (points 5 and 6).
Protection against corruption and self-learning systems
Annex III, section 1.1.9 requires that connecting another device or remote access cannot create a hazard, that safety-critical software and data are protected against corruption, and that the machine records interventions and shows its installed safety software. Under section 1.2.1, control systems must withstand reasonably foreseeable malicious attempts and log safety software updates; self-evolving systems must stay within their defined task and movement space and remain correctable at any time.
The technical file covers the source code or programming logic of safety software, which authorities can request, and describes sensor-driven or autonomous systems (Annex IV, Part A, points (m) and (n)). Connected machines can also fall under the Cyber Resilience Act from 11 December 2027 (Recital 53 and Article 71(2) of Regulation (EU) 2024/2847); see our article on its reporting duties.
Digital instructions and a digital Declaration of Conformity
Instructions for use may be digital (Article 10(7)) if you:
- mark on the machine, or where impossible on the packaging or an accompanying document, how to access them;
- provide a format users can print, download and save;
- keep them online for the machine's expected lifetime and at least 10 years.
Paper stays in two cases: on request at the time of purchase, free of charge within one month, and for machines that non-professionals may use, the essential safety information always on paper. Each member state sets the language.
The Declaration of Conformity may accompany the machine or be reached via an internet address or machine-readable code in the instructions, online for at least 10 years (Article 10(8)). Under Annex V, it names manufacturer and, where applicable, representative, and lists the harmonized standards with their Official Journal publication dates. The Directive's “person authorized to compile the technical file” disappears.
Substantial modification: when a retrofit creates a new manufacturer
A substantial modification is a physical or digital change after placing on the market or putting into service that the manufacturer did not foresee or plan, that creates a new hazard or increases a risk, and that requires new protective devices integrated into the safety control system or measures for stability or strength (Article 3(16)).
Whoever makes it becomes the manufacturer of the modified machine (Article 18); repair and maintenance that do not affect compliance do not count (Recital 26). Describe foreseen updates in your risk assessment, and tell EU customers and integrators that retrofits touching your safety controller can make them manufacturers.
What your EU Authorized Representative must be able to do
Article 12 makes appointing an Authorized Representative optional, but Article 4 of Regulation (EU) 2019/1020 requires an EU economic operator for machinery (Recital 8). Without an EU manufacturer or importer, that is usually your representative (see Authorized Representative or importer).
Under Article 12(2), the mandate must at least cover:
- keeping the technical file and the declaration available to authorities for at least 10 years after placing on the market;
- providing all conformity information and documents on reasoned request;
- cooperating with authorities on action against risks.
Regulation (EU) 2019/1020 also requires the operator's name and postal address on the product, packaging, parcel or accompanying document; without them, customs suspend release (Articles 4(4) and 26(1)(d)).
The big change: design and drawing up the technical file can no longer be part of the mandate (Article 12(1)), unlike under Article 5(1) of the Directive. Liability reaches the representative too: for products placed on the market after 9 December 2026, importer and Authorized Representative can be liable alongside a manufacturer outside the EU (Product Liability Directive, Article 8(1)(c) of Directive (EU) 2024/2853).
Checklist for non-EU manufacturers: seven steps before 20 January 2027
- Plan per unit. Machines finished, cleared by customs or sold directly from 20 January 2027 need Regulation conformity.
- Classify. Annex I, Part A, Part B or neither? Machine learning in safety functions? Contact your notified body early.
- Update the risk assessment for Annex III, including sections 1.1.9, 1.2.1 and your machine type's chapter; check your standards against the new list.
- Complete the technical file under Annex IV, Part A, including safety software, and keep it for at least 10 years (Article 10(3)).
- Rewrite declaration and marking. Use the Annex V model; put name, postal address, digital contact, model and year on the machine (Article 10(5) and (6)); for partly completed machinery, the declaration of incorporation (Article 11).
- Prepare the instructions. Content under Annex III, 1.7.4, member state languages, digital access, paper on request, paper safety information.
- Secure your EU economic operator. Update the mandate (Article 12(2); Article 4(3) of Regulation (EU) 2019/1020) and put its details on product or packaging.
Practical example: a U.S. packaging machine maker at the cut-off date
A U.S. maker of case packers for food producers has no EU subsidiary and has appointed an EU Authorized Representative. Four machines:
| Unit | What happens | Date that counts | Rules |
|---|---|---|---|
| 1 | Finished November 2026, sold directly to a plant in Poland, order accepted December 2026, customs January 2027 | Accepted order | Directive |
| 2 | Finished December 2026, bought and imported by an EU dealer, released by customs on 25 January 2027 | Customs release | Regulation; the dealer adds its details as importer (Art. 13(3)) |
| 3 | Ordered October 2026, finished February 2027 | Completion and supply | Regulation |
| 4 | Installed 2025; in 2027 the customer adds a robot cell with changes to the safety controller | Modification | Customer becomes manufacturer if the change is substantial (Art. 18) |
Unit 1 may name both acts in its declaration; units 2 and 3 need the Annex V declaration.
Common mistakes when switching to the Regulation
- Using 14 January 2027. That is the uncorrected text.
- Planning by model. Each unit placed on the market after the cut-off needs Regulation conformity.
- Dropping paper entirely. Paper on request and paper safety information for non-professional use remain.
- Treating all AI as Part A. Only machine learning that ensures safety functions counts.
- Leaving the technical file to the representative. Article 12(1) excludes it from the mandate.
Conclusion: plan per unit, not per model
The Machinery Regulation 2027 is decided unit by unit: classify your machines under Annex I and update risk assessment, technical file, declaration and instructions together.
Keep the roles apart. As your EU Authorized Representative, Representa GmbH acts under a written mandate: we provide our name and address for packaging and the Declaration of Conformity, keep your technical documentation for 10 years and handle authority inquiries. Separately, our CE marking service helps you identify the applicable legislation and harmonized standards and compile and review your technical documentation. Responsibility for the technical documentation and the Declaration of Conformity stays with you as manufacturer.
Frequently asked questions
When does the EU Machinery Regulation apply: 14 or 20 January 2027?
From 20 January 2027. The text published in June 2023 said 14 January 2027, but a corrigendum in the Official Journal (OJ L 169, 4 July 2023) corrected this and several other dates. The Machinery Directive 2006/42/EC is repealed with effect from the same day (Article 51(2) of Regulation (EU) 2023/1230).
Can machines built under the Machinery Directive still be sold after 20 January 2027?
Yes, if they were placed on the market in conformity with Directive 2006/42/EC before that date (Article 52(1)). Placing on the market is judged per unit: a unit of the same model placed on the market on or after 20 January 2027 must meet Regulation (EU) 2023/1230.
Do I still have to supply paper instructions?
Not by default. Digital instructions are allowed under Article 10(7), but on request at the time of purchase you supply paper instructions free of charge within one month. For machines that non-professional users may use, the essential safety information must always be on paper.
Does every machine with AI need a notified body?
No. Annex I, Part A, points 5 and 6 cover safety components and embedded systems with fully or partially self-evolving behaviour using machine learning that ensure safety functions. Other AI features do not put a machine into Part A; the usual rules of Article 25 apply.
Do I need an EU Authorized Representative for machinery?
Usually yes, if there is no EU importer. Article 12 makes the appointment optional, but machinery may only be placed on the market if an EU economic operator handles the tasks in Article 4 of Regulation (EU) 2019/1020 (Recital 8). Without an EU manufacturer or importer, that is typically an Authorized Representative with a written mandate.