CE Marking for Machinery: Step-by-Step Guide for Exporters to the EU

Published 30 August 2026Based on Directive 2006/42/EC, the law in force until 19 January 2027

CE marking is the ticket into the EU market for machinery, and it works differently from most third-country systems: it is a manufacturer’s self-declaration backed by documentation, not a government approval. This guide walks through the ten steps under Directive 2006/42/EC, flags the traps that catch non-EU manufacturers, and notes what changes in 2027.

Three misconceptions that cost exporters money

“We are UL listed, so we are basically compliant.”

NRTL marks have no legal effect in the EU. Regulation (EC) 765/2008 makes CE the only marking attesting conformity with EU harmonisation law. Your UL test data can feed the technical file, but the assessment runs against the EU requirements and standards, for example EN 60204-1 rather than NFPA 79.

“We need to get a CE certificate from an EU body.”

For machinery outside Annex IV there is no certificate at all, only your own declaration. Paying for a generic “CE certificate” adds cost, not legal effect. What authorities check is your technical file, your risk assessment and your declaration.

“Standards are optional, so we can skip them.”

Standards are voluntary, the essential requirements are not. Harmonised standards are the practical way to prove conformity, because they carry a presumption of conformity (Article 7(2)). Skipping them means proving equivalence of your own solution requirement by requirement.

The CE process in ten steps

Confirm what you are shipping: machinery or partly completed machinery

The Directive covers machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes, webbing, removable mechanical transmission devices, and partly completed machinery. The distinction that matters most for exporters: a complete machine gets the full CE process, while partly completed machinery (an assembly that cannot yet perform a specific application on its own, Article 2(g)) is handled under Article 13 with a Declaration of Incorporation instead of CE marking. If you ship subsystems into OEM lines, read the partly completed machinery section below carefully.

Identify all applicable EU legislation

The Machinery Directive rarely travels alone. Depending on the product, the EMC Directive 2014/30/EU, the ATEX Directive 2014/34/EU, the Pressure Equipment Directive 2014/68/EU or the Radio Equipment Directive 2014/53/EU may apply in parallel, and each applicable act must be listed on the declaration. Getting this list right at the start prevents redesign later.

Run the risk assessment (this is a legal obligation, not best practice)

Annex I obliges the manufacturer to carry out a risk assessment to determine which essential health and safety requirements (EHSR) apply, and to design and build the machine taking its results into account. The recognised method standard is EN ISO 12100, which is harmonised under the Directive and therefore confers a presumption of conformity for what it covers: define the limits of the machine, identify hazards across all life phases, estimate and evaluate risks, then reduce them.

Reduce risks in the mandatory 3-step order

Annex I section 1.1.2(b) fixes the hierarchy, in the order given: first eliminate or reduce risks through inherently safe design, then apply safeguarding for risks that cannot be designed out, and only then inform users about residual risks, training needs and personal protective equipment. A warning sticker where a guard was feasible does not survive a market surveillance check, or a courtroom.

Select and apply standards

Harmonised standards listed in the Official Journal give a presumption of conformity for the requirements they cover (Article 7(2)). The machinery world is organised in three levels: type A (EN ISO 12100, basic concepts), type B (groups of aspects, such as EN ISO 13849-1 for safety-related controls or EN 60204-1 for electrical equipment) and type C (complete requirements for one machine family). A type C standard, where one exists for your machine, is the fastest route to a defensible design. Standards remain voluntary; the legal requirements are the EHSR.

Check Annex IV and pick the conformity assessment route

For machinery not listed in Annex IV, the route is self-assessment with internal production checks (Article 12(2), Annex VIII); no notified body is involved. For Annex IV machinery built fully to harmonised standards that cover all relevant EHSR, you may choose: self-assessment, EC type-examination (Annex IX), or full quality assurance (Annex X) (Article 12(3)). If your Annex IV machine is not fully covered by harmonised standards, a notified body becomes mandatory (Article 12(4)).

Assemble the technical file (Annex VII A)

The construction file includes the general description, overall and control-circuit drawings, detailed calculations and test results needed to check conformity, the risk assessment documentation with the list of applicable EHSR and the protective measures taken, the standards used, test reports, the instructions, declarations for incorporated partly completed machinery, and the EC Declaration of Conformity. It must be available for 10 years from the date of manufacture and capable of being assembled on a reasoned request; failing to produce it is in itself grounds for doubting conformity.

Write the instructions and handle languages

Every machine ships with instructions in the official language or languages of the member state where it is placed on the market or put into service (Annex I 1.7.4). Selling into five EU countries can mean five language versions, each marked either as “Original instructions” or as “Translation of the original instructions” accompanied by the original. Plan the translation workflow early; it is a classic critical-path item for first-time exporters.

Draw up the EC Declaration of Conformity

The declaration follows Annex II 1.A with ten fixed particulars, including the machine identification, the applied directives and standards, and, decisive for non-EU manufacturers, the name and address of the person authorised to compile the technical file, who must be established in the Community. Keep the original for at least 10 years after the last unit is manufactured.

Affix the CE marking and ship

The CE marking goes on the machine visibly, legibly and indelibly (Article 16(2)), in the graphic form of Annex III with at least 5 mm height, next to the manufacturer’s name and applied with the same technique. Where full quality assurance was the route, the notified body’s identification number follows the marking. After that: keep the file, monitor standards for changes, and remember that substantial modifications later can restart the whole process.

Special case: partly completed machinery

Many exporters do not ship complete machines but subsystems: robot arms without end effectors, drive units, feeder systems. These are partly completed machinery under Article 2(g) and follow Article 13 instead of the full CE process. They carry no CE marking under the Machinery Directive. Instead you prepare the relevant technical documentation (Annex VII B), assembly instructions (Annex VI) and a Declaration of Incorporation (Annex II 1.B), which states, among other things, which essential requirements you applied and satisfied. The EU integrator who builds your subsystem into a final machine takes over the complete conformity assessment. Getting this boundary wrong in the contract, who declares what, is one of the most common disputes between non-EU suppliers and EU integrators.

FAQ

Frequently asked questions

Do I need a notified body to CE mark machinery?

Usually not. For machinery not listed in Annex IV of Directive 2006/42/EC, the only conformity assessment route is the manufacturer's self-assessment with internal checks (Article 12(2), Annex VIII); no third party is involved. A notified body is mandatory only for Annex IV machinery that is not manufactured fully in accordance with harmonised standards covering all relevant essential requirements (Article 12(4)). Even for Annex IV machinery, self-assessment remains available if harmonised standards exist and cover all relevant requirements and you apply them in full (Article 12(3)).

Is there an official CE certificate issued by an EU authority?

No. CE marking is a manufacturer's self-declaration, documented in the EC Declaration of Conformity that you draw up and sign yourself. No EU authority issues a general CE certificate for machinery. Certificates from notified bodies exist only for the specific Annex IV routes (EC type-examination, full quality assurance). Offers of a universal 'CE certificate' for ordinary machinery are a marketing product, not a legal document.

Does UL, CSA or another NRTL listing count towards CE?

No. Third-country certification marks have no legal effect for EU market access. Regulation (EC) 765/2008 makes the CE marking the only marking that attests conformity with EU harmonisation legislation, and only the manufacturer or its authorised representative may affix it. Test data from NRTL programmes can inform your technical file, but the assessment must be made against the EU essential health and safety requirements and the standards that support them, such as EN 60204-1 instead of NFPA 79 for electrical equipment.

In which language must the instructions be supplied?

Instructions must accompany the machinery in the official EU language or languages of the member state where it is placed on the market or put into service (Annex I section 1.7.4). English alone is only sufficient in member states where English is an official language. The language versions must be marked 'Original instructions', or 'Translation of the original instructions' together with a copy of the original instructions.

Does the technical file have to be stored in the EU?

No. The Annex VII technical file does not have to be located in EU territory or exist permanently in assembled form. It must, however, be capable of being assembled and made available to authorities within a period commensurate with its complexity, for at least 10 years after the date of manufacture (for series production, of the last unit). The EC Declaration of Conformity must name a person established in the Community who is authorised to compile the file, which is the point where non-EU manufacturers need an EU-based contact.

What about machines I ship for integration into a production line?

An assembly that is almost machinery but cannot perform a specific application by itself, such as a robot arm without its end effector or a drive system, is 'partly completed machinery' (Article 2(g)). It is not CE marked under the Machinery Directive. Instead it ships with relevant technical documentation per Annex VII B, assembly instructions per Annex VI, and a Declaration of Incorporation per Annex II 1.B, and the business that integrates it runs the conformity assessment for the final assembly.

Is CE marking also accepted in the United Kingdom?

For machinery on the Great Britain market: yes, indefinitely. The UK removed the end date for recognition of EU conformity assessment including CE marking for machinery in 2024 (SI 2024/696), and legislation made in July 2026 (SI 2026/867) extends that recognition from 20 January 2027 to machinery complying with the new EU Machinery Regulation 2023/1230. In Northern Ireland, EU rules apply under the Windsor Framework, so CE marking is required there anyway. One CE-compliant machine can therefore serve the EU and the whole UK.

How does the process change with the new Machinery Regulation in 2027?

The structure stays similar (essential requirements, risk assessment, technical file, declaration, CE marking), but from 20 January 2027 Regulation (EU) 2023/1230 replaces the Directive with adjusted annex numbers, new requirements on cybersecurity, AI-based safety functions and digital instructions, and six high-risk categories in Annex I Part A where a notified body is always mandatory. Units placed on the EU market from that date must conform to the Regulation; there is no sell-off period for new machines built to the Directive.

Want a tool to handle all of this yourself — in English?

This guide is written by the team behind CE-Copilot, a software platform covering the whole EU CE process for machinery: risk assessment per EN ISO 12100, research across 3,100+ standards with harmonisation status, functional safety documentation, the technical file, and EU declarations of conformity with document exports in English, French, Italian and German. The platform interface is currently German — we are gauging demand for a full English version.

Exporting machinery to the EU and want to run compliance in-house, in English? Tell us — your message directly shapes whether and how fast the English version ships.

More English guides

EU Machinery Regulation 2023/1230: What Changes on 20 January 2027 Exporting Machinery to the EU Without an EU Entity

This guide is general information for machinery manufacturers, verified against the official EU legal texts as of 30 August 2026. It is not legal advice. For decisions about your specific product, consult the legal texts (EUR-Lex) or a qualified advisor.