In the EU, an inspection robot may only be placed on the market with CE marking and an EU declaration of conformity. CE marking is not an authority's seal of approval, but the manufacturer's declaration that all applicable legal acts are met. For an inspection robot, these are regularly four to six legal acts at the same time – and this is precisely where the most common gap lies: many declarations presented cover only some of them.
What CE marking means – and what it does not
CE marking is a declaration by the manufacturer, not a certification. Nobody checks it in advance, no authority grants it, and in itself it says nothing about quality.
What it means: the manufacturer declares that it has carried out a conformity assessment procedure, that technical documentation exists and that the product meets all relevant requirements. The correctness of this declaration is only checked after the fact – by market surveillance or, in the event of damage, in court.
For procurement, this gives rise to a practical principle: The CE mark on the device is not evidence. The evidence is the EU declaration of conformity – and it has to be read.
The wording “CE certified” is never correct. CE is a marking, not a certification.
Which legal acts apply to an inspection robot?
As a rule, several at the same time. Which ones exactly depends on the equipment.
| Legal act | Applies if | Note |
|---|---|---|
| Machinery Directive 2006/42/EC | always | until 19 January 2027 |
| Machinery Regulation (EU) 2023/1230 | always | from 20 January 2027 |
| Radio Equipment Directive 2014/53/EU | Wi-Fi, Bluetooth, mobile radio, GNSS reception | affects practically every inspection robot |
| EMC Directive 2014/30/EU | for parts not covered by the Radio Equipment Directive | delimitation in the individual case |
| RoHS Directive 2011/65/EU | always | restrictions of substances |
| Batteries Regulation (EU) 2023/1542 | with a built-in battery | gradually replaces the Batteries Directive |
| Low Voltage Directive 2014/35/EU | for the charging station | separate product, separate consideration |
| ATEX Directive 2014/34/EU | only for use in Ex zones | determined by design, cannot be retrofitted |
| AI Act (EU) 2024/1689 | with AI components | since 2026 predominantly via machinery legislation |
Table scrolls sideways.
Two points that are often overlooked.
First, the Radio Equipment Directive also covers pure receivers. A robot with a GNSS or RTK module falls within its scope, even if it transmits nothing.
Second, the charging station is a separate product. It has its own conformity requirements and needs its own declaration or must be expressly included in that of the robot. It is regularly missing from procurement documents.
Who is responsible?
Product law knows four roles. Which one you take on determines the scope of obligations – and liability.
Manufacturer. Carries out the conformity assessment, draws up the technical documentation and the declaration of conformity, affixes the CE marking, supplies the operating manual. Bears full responsibility.
Authorised representative. A person established in the EU with a written mandate from the manufacturer. Keeps documents available for the authorities. Without an authorised representative, market surveillance has no European point of contact.
Importer. Whoever places a product from a third country on the EU market for the first time. The importer may only import compliant products, must check whether the manufacturer has carried out the procedure, must enclose the operating manual in the language of the country, must state name and address on the product and keep the declaration of conformity available for ten years.
Distributor. Whoever resells a product already placed on the EU market. Checks formally: is the CE marking present, are the documents enclosed, is the manual available in the right language?
The transition from distributor to importer is the step in this chain with the greatest commercial consequences. It is not triggered by a decision, but by the fact of direct import.
And the operator? In product law, the operator has no role. The operator is subject to occupational safety and health law: workplace risk assessment, safe provision of the work equipment, instruction. There is, however, one exception – see the following section.
When does the operator become the manufacturer?
When the operator makes a substantial modification to a machine.
This is not a theoretical case. Anyone who retrofits an inspection robot with additional sensors, a manipulator or their own control logic potentially intervenes in the safety-related design. If this creates a new hazard or increases an existing one without the existing protective measures being sufficient, the machine is deemed to have been substantially modified.
The consequence: whoever makes the modification becomes the manufacturer of the modified machine. They must carry out the conformity assessment, draw up technical documentation, issue their own declaration of conformity and affix the CE marking.
Of practical importance for anyone who wants to integrate payloads themselves: replacing a camera with an equivalent model within the intended interface framework is generally unproblematic. Mounting a manipulator is not. In case of doubt, this question should be checked before the conversion – not afterwards.
More on this in the article on the Machinery Regulation, which regulates this case in the text of the regulation for the first time.
How do I check an EU declaration of conformity?
A declaration of conformity is usually a one-page document. Six checking steps are enough to find the most common gaps.
1. Are all relevant legal acts named? A declaration that lists only electromagnetic compatibility and radio equipment is incomplete for a machine. Machinery legislation must be named.
2. Does the product designation match exactly? Model, variant, type designation. A declaration for a base model does not automatically cover its Pro variant.
3. Is a person established in the EU named for the technical documentation? This is mandatory information and one of the quickest checkpoints for imported devices. If it is missing, market surveillance cannot request the documentation – and the declaration is formally defective.
4. Which harmonised standards were applied? This is where the actual scope of testing shows. For radio, these are typically standards from the EN 300 328, EN 301 893 and EN 303 413 series, for electromagnetic compatibility the EN 61000-6 series, for the electrical equipment EN 60204-1.
5. Was a notified body involved – and was it necessary? If a notified body is named, its name, address and identification number belong with it. The identification number can be checked in the European Commission's NANDO database.
6. Are place, date and signatory stated? With the signatory's function. An undated declaration is worthless.
Self-assessment or notified body?
Most machines are assessed by the manufacturer itself. A notified body is mandatory only for certain, expressly listed categories.
For inspection robotics, this is not required as a rule – with one important exception: safety technology with fully or partially self-evolving behaviour based on machine learning belong, under the Machinery Regulation, to the categories that require the involvement of a third party.
This gives rise to a concrete question for every supplier: Which safety functions of the system are based on machine learning, and which work deterministically? Navigation and image analysis using learning methods are not critical. A learning collision shutdown is.
What changes on 20 January 2027?
From this date, the Machinery Regulation (EU) 2023/1230 applies. It is a regulation, not a directive – so it applies directly, without national transposition.
The most important changes for robotics: cybersecurity becomes an essential safety requirement, self-evolving behaviour is expressly addressed, the digital operating manual becomes permissible, and substantial modification is regulated in the text of the regulation for the first time.
Products placed on the market before the cut-off date are protected by grandfathering. For everything after that, the new framework applies – relevant for procurements that run over the turn of the year.
In detail in Machinery Regulation (EU) 2023/1230 – what applies to robotics from 20 January 2027.
Typical gaps in imported devices
Recurring patterns of findings from practice, in descending order of frequency:
The declaration covers only one area. Often there is evidence on electromagnetic compatibility, but none on machinery legislation.
Evidence from a third country is presented as EU evidence. A US confirmation of conformity under FCC rules is not EU evidence. In addition, it usually covers only unintentional emissions – not the intended transmission of Wi-Fi, radio and RTK modules.
No person established in the EU for the technical documentation.
The battery is certified to a national third-country standard. For the EU market, other evidence is required, plus registration before the first delivery.
No risk assessment evident. It is the basis of every conformity assessment under machinery legislation. If it is missing, no valid declaration can exist – even if one is presented.
The operating manual is available only in English, often with version numbers below 1.0.
The charging station is missing from the documents entirely.
Checklist for procurement
- EU declaration of conformity for exactly the model procured, as a PDF before the contract is concluded
- List of all legal acts named in it
- Test reports for radio modules according to European standards
- Evidence of battery certification
- Confirmation that a risk assessment exists
- Operating manual in German, released version
- Conformity of the charging station, evidenced separately
- Statement of which safety functions are based on machine learning
- For direct import: who takes on the importer role
This checklist will be offered as a download once the template exists.
If one of these points is missing, it is not an exclusion criterion – but it shifts effort, costs and liability. This shift should be reflected in the price.
Conformity belongs among the exclusion criteria of a tender, not among the award criteria. A device that may not lawfully be placed on the EU market is not an admissible offer, regardless of price.
Sources
- Directive 2006/42/EC on machinery European Union accessed 15 August 2026
- Regulation (EU) 2023/1230 on machinery European Union accessed 15 August 2026
- Directive 2014/53/EU on the making available on the market of radio equipment European Union accessed 15 August 2026
- Directive 2014/30/EU relating to electromagnetic compatibility European Union accessed 15 August 2026
- Regulation (EU) 2023/1542 concerning batteries and waste batteries European Union accessed 15 August 2026
- Regulation (EU) 2019/1020 on market surveillance and compliance of products European Union accessed 15 August 2026
- The ‘Blue Guide’ on the implementation of EU product rules European Commission accessed 15 August 2026
- NANDO – database of notified bodies European Commission accessed 15 August 2026
Change log (1)
- 5 October 2026 Initial publication First publication of the English version.