This guide is general information, not legal advice. Confirm the classification of a specific product with a notified body or compliance adviser.
1. First decide: are you selling partly completed machinery or complete machinery?
This is where every EU compliance path starts. The table follows Articles 2(a) and 2(g) of the Machinery Directive4 and the European Commission's Guide to application of the Machinery Directive, Edition 2.3 (April 2024), §38 and §463.
| What you deliver | Classification | What the manufacturer provides | Basis |
|---|---|---|---|
| Standard robot arm (with or without controller), no end-effector, no specific application | Partly completed machinery (usually) | Declaration of Incorporation (DoI) + assembly instructions; no CE marking under the Machinery Directive | Guide §46: industrial robots "are usually designed without a specific application until incorporated into the final machinery"; §131 |
| "Stand and function alone" robot with both an end-effector and a control system, able to perform a specific application by itself | Complete machinery | Technical file + EC Declaration of Conformity (DoC) + CE marking | Guide §46: only such a robot is complete machinery |
| Robot system that can perform its application but lacks protective means such as guards | Not partly completed machinery | Must not be CE marked or placed on the market; complete the safeguarding first | Guide §46 |
| Integrated robot cell or line (common function, functional link, common control system: all three) | Assembly of machinery (complete machinery) | Whoever assembles it is its manufacturer: whole-assembly risk assessment, DoC + CE | Guide §38 |
Classification depends on the final delivered configuration and intended use, not on the product name. The same robot model is partly completed machinery when sold as a bare arm, and complete machinery when delivered as a welding cell with torch, control system and guarding.
- CE marking under other legislation. Partly completed machinery does not carry CE marking under the Machinery Directive. But if other CE legislation applies (for example the Radio Equipment Directive), it may carry CE for that legislation. The DoC must then say it covers only that legislation, and a DoI under the Machinery Directive is still required3.
- Batch deliveries. When you supply a batch of identical products to one identified integrator, the DoI and assembly instructions can travel with the first delivery, provided you make clear they apply to the whole batch3.
If you sell only the arm and a European integrator builds the cell, the integrator is the manufacturer of that assembly and is responsible for its compliance and CE marking3. Your DoI and assembly instructions go into the integrator's technical file.
After January 2027. Article 3(10) of Regulation (EU) 2023/1230 keeps the same test: an assembly that "cannot in itself perform a specific application"1. The Commission's guidance on the new Regulation is outside what we verified for this article. The Machinery Directive Guide interpretation above applies directly only to products placed on the market up to 19 January 20272.
2. Which laws and standards apply?
| Requirement | Nature | Who handles it | Key points |
|---|---|---|---|
| Machinery Directive 2006/42/EC (to 19 Jan 2027) / Machinery Regulation (EU) 2023/1230 (from 20 Jan 2027) | Legally mandatory | Manufacturer; the integrator for the complete machinery it builds | Risk assessment, technical file, DoI or DoC + CE24 |
| Low Voltage Directive (LVD) | Not applied separately to machinery under the Machinery Directive; its safety objectives apply, but conformity assessment follows the Machinery Directive only | Manufacturer | Design electrical safety to Annex I section 1.5.1 of the Machinery Directive4 |
| Language of instructions | Legally mandatory | Manufacturer or authorised representative | Official language(s) of the member state where the machinery is placed on the market or used; translations must come with the "original instructions"4 |
| Harmonised standards: EN ISO 10218-1/-2, EN ISO 12100, EN 60204-1, EN ISO 13849-1 | Voluntary; applying them is a recognised way to show the essential requirements are met | Manufacturer / integrator | Customers and integrators also use them to check your documents |
Other EU legislation, such as EMC, RoHS, the Radio Equipment Directive and the Cyber Resilience Act, may also apply and must be checked product by product. We will cover these in later articles.
Key change under the new Regulation: AI-based safety functions need third-party assessment. Annex I Part A, items 5 and 6 of the Machinery Regulation cover "safety components with fully or partially self-evolving behaviour using machine learning approaches" and machinery embedding such systems1. Under Article 25(2), these products may only use EU type-examination (modules B+C), full quality assurance (H) or unit verification (G). Self-declaration is not allowed, so a notified body must be involved1. Manufacturers of AI-vision safety or adaptive collaborative functions should plan for this early.
3. The compliance path in outline
There are four stages: define the product configuration → assess risks and design and verify to harmonised standards → compile the technical file and instructions → sign the DoI or the DoC (and affix CE).
A separate guide will cover the documents for each stage, how to write the declarations and how to work with test bodies.
When must a notified body be involved? It depends on the final product configuration, and the answer differs between the current Directive and the Regulation that applies from 2027:
- Machinery Directive (to 19 January 2027). Industrial robots are not among the 23 high-risk categories in Annex IV4. Machinery outside Annex IV follows the internal checks procedure (Annex VIII), with no notified body (Article 12(2); Guide §128)3. If your delivery includes an Annex IV product placed on the market as a separate safety component, such as a logic unit ensuring safety functions (item 21) or a protective device detecting persons (item 19), Article 12(3)/(4) applies to it. Partly completed machinery follows Article 13: DoI and assembly instructions.
- Machinery Regulation (from 20 January 2027). The Annex I Part A and Part B lists do not name industrial robots either. Part A items 5 and 6 do cover machine-learning safety components with self-evolving behaviour and machinery that embeds them; these require modules B+C, H or G, with a notified body (Article 25(2))1.
Even where self-assessment applies, you may use any competent body for testing and include its reports in the technical file. That body then acts outside its notified-body role and must not use its notified-body number3. This is why a "CE certificate" on its own does not prove compliance.
Cost and time: we do not publish unverified figures. Ask at least two bodies for quotes, and confirm which standards and documents each quote covers.
Can existing reports be reused? Tests to ISO/IEC standards, including ISO 10218 tests done for the US market, can go into the technical file if the model and the edition of the standard match. A US NRTL listing does not replace an EU declaration, and vice versa.
4. Who is responsible for what
| Role | Main obligations |
|---|---|
| Chinese manufacturer | Compliant design, technical file, DoI/DoC, marking, instructions and translations |
| Authorised representative | May sign declarations and provide translations of the instructions under the manufacturer's mandate4 |
| System integrator | Manufacturer of the complete machinery it assembles: DoC + CE3 |
| Importer, distributor, end user | Each has legal obligations; covered in the later CE procedure guide |
5. Common mistakes
- Buying a "CE certificate" as proof of compliance. European customers and integrators want the DoI or DoC, a technical file summary and test reports.
- CE marking a generic robot arm under the Machinery Directive. Professional integrators will immediately question your compliance knowledge.
- Forgetting the 2027 switch. The Regulation applies to products placed on the market from 20 January 20272; update documents and declarations in good time.
- English-only instructions. German customers need a German version4.
- No European service or spare parts. As in the US, this is one of the main reasons suppliers are rejected.
6. Once you are ready, how do you find European customers?
- Start with Germany. According to Google Ads keyword data (October 2026), "Maschinenverordnung" averages about 2,900 German searches a month, and "Maschinenverordnung 2027" grew from about 480 to about 1,300 within a year, a sign that German companies are watching the switch.
- System integrators and agents. Lower the barrier to a first trial with your DoI, assembly instructions, German manuals and demo units.
- Trade shows. Book meetings with integrators and potential agents in advance.
- German/English website with Google SEO and ads. Publish your compliance document list and application cases, so compliance readiness becomes a trust signal.
For the US, read Exporting industrial robots to the US.
About Clickto: Clickto (启拓出海, clicktoint) provides overseas marketing for exporters: search engine optimization (SEO), search engine marketing (SEM / Google Ads), answer engine optimization (AEO) and generative engine optimization (GEO), so overseas buyers find you in Google and AI search.