CE Marking for Robots: Compliance and EU Regulation 2023/1230

The CE marking is not a quality seal but a legally prescribed declaration of conformity by the manufacturer or the entity placing the product on the market. It signals to the market surveillance authorities that the product meets the essential safety and health requirements of the relevant EU directives. For robots in professional environments such as care or logistics, these are primarily the Machinery Directive 2006/42/EC, the EMC Directive on electromagnetic compatibility, and the Radio Equipment Directive.

An essential aspect for operators is the distinction between partly completed machinery and complete machinery. Many robot arms are delivered as partly completed machinery and only acquire their final intended use through the integration of grippers, sensors, and the specific programming. At this moment, the integrator or the operator legally becomes the manufacturer and must subject the entire system to a new conformity assessment. werob takes on this responsibility as a systems integrator and delivers turnkey systems that already contain all necessary certifications for the specific area of use.

The documentation obligation includes a comprehensive risk assessment, the operating instructions in the national language, and the technical file. These documents must be available for authorities for ten years. In industries with high public traffic, such as hospitality or retail, compliance with ISO 13482 for personal assistant robots is also decisive in order to guarantee safety when interacting with people.

On 20 January 2027, the EU Machinery Regulation 2023/1230 becomes binding and replaces the previous Machinery Directive. In contrast to a directive, a regulation does not first have to be translated into national law but applies directly in all EU member states. This change is the most important regulatory change for the robotics industry in two decades. It takes account in particular of the rapid development in the areas of artificial intelligence and cybersecurity.

A central point of the new regulation is the classification of certain machinery as high-risk products. Robots that have AI systems controlling safety functions are subject to stricter conformity assessment procedures. Here, a simple self-declaration by the manufacturer is often no longer sufficient. Instead, a notified body must be involved in the certification process. This applies in particular to autonomous systems that operate in unstructured environments, such as those found in care or in public spaces.

For operators this means that existing fleets and planned investments must already be examined today for the requirements of 2027. werob offers an integrated compliance path for this. Because werob acts hardware-agnostically and carries more than 44 OEM partners in its catalog, we can specifically select the manufacturers that already meet the requirements of the new regulation today or offer a clear migration path. This protects your investments from premature loss of value due to regulatory exclusions.

Many companies underestimate the liability risk when deploying robots. As soon as a robot is integrated into an existing workflow, an overall system arises. If the operator makes substantial changes to the machine, for instance by altering the software logic or attaching non-certified components, the manufacturer's responsibility passes to them. In the event of an accident, management is personally liable if there is no valid risk assessment for the overall system.

In the care sector, where relief on the medication round can lead to cost savings of €92,000 per site per year, the temptation is great to implement systems quickly and without in-depth examination. Yet it is precisely here that compliance with ISO 13482 and the care home inspectorate requirements is essential. A non-compliant robot can lead to the loss of the operating license for the entire facility. werob minimizes this risk through the live Cockpit, which monitors the status of the fleet with regard to hardware, infrastructure, and regulatory compliance in real time.

The liability chain begins with the OEM, runs via the integrator, and ends with the operator. Through werob's outcome-only model, you only pay once the system is running safely and compliantly. This shifts the initial risk of commissioning to the integrator. We ensure that all connectors into your stack, such as to SAP EWM or MatrixCare, do not impair the integrity of the safety functions and that GDPR conformity in data processing is maintained.

While industrial robots traditionally work behind protective fences, service robots operate in the immediate vicinity of people. The ISO 13482 standard defines the safety requirements for personal assistant robots. It distinguishes between mobile servant robots, physical assistant robots, and person carrier robots. For operators in hospitality, who achieve cost relief of €112,000 per year through robots in room service, this standard is the basis for safe operation in hotel corridors and elevators.

Among other things, the standard requires that the robot stops or avoids immediately upon contact with an obstacle or a person, without causing injuries. This is achieved through a combination of sensor technology (LiDAR, 3D cameras) and mechanical limitations. A CE marking based on ISO 13482 is effectively indispensable for use in public areas in order to meet the requirements of liability insurers.

werob uses the Spec Engine to examine, as early as the planning phase, which standards are relevant for your specific workflow. Within 48 hours, we translate your requirements into a technical specification that takes all regulatory hurdles into account. Whether it is about cleaning kitchen floors in the F&B area, which enables relief of €44,000, or about the autonomous patrol in logistics with €68,000 in savings: the safety specification is always the foundation of the quote.

The market for service robotics is strongly dominated by manufacturers from Asia, including brands such as Keenon or Pudu. These offer technologically highly developed systems on attractive terms. The challenge for European operators, however, is that many of these manufacturers have no physical presence in the EU that can act as authorized representative for the CE marking. Without a responsible party based in the EU, placing on the market is legally problematic.

werob acts here as a decisive link. We are the systems integrator that takes over the conformity assessment for the European market. We examine the documentation of the 44+ OEM partners in our catalog against the strict EU requirements and the upcoming Machinery Regulation 2023/1230. This enables our customers to access the world's best hardware without having to deal with the complex import and compliance questions.

This hardware-agnostic approach prevents vendor lock-in. Should a manufacturer no longer be able to meet the EU's regulatory requirements, the werob system allows a fast switch to another ranked OEM from the Supplier Match. The integration into your stack, for example via Mews or Toast, remains stable through our pre-built connectors. You receive the operational performance, while werob ensures the regulatory integrity.

Every CE marking is based on a thorough risk assessment according to ISO 12100. Here, all life phases of the robot must be considered: from transport through commissioning and operation to maintenance and disposal. For an operator in logistics, this means, for example, analyzing the interaction between autonomous yard patrols and manned forklifts. The goal is risk reduction through design measures, technical protective measures, or user information.

A common mistake is the assumption that the robot manufacturer's CE marking is sufficient for the entire deployment site. As soon as the robot interacts with the building infrastructure, however, such as calling elevators or driving through automatic doors, this interface must be assessed from a safety standpoint. werob automates large parts of this process through the Spec Engine, which was trained on data from more than 35,000 projects. We identify potential danger points in your workflow within 48 hours.

The technical file created as part of the risk assessment is your protective shield during operational inspections. It contains circuit diagrams, calculations on stability, software validations, and evidence of cybersecurity in accordance with IEC 62443. At a time when networked fleets are becoming the standard, protection against unauthorized access is not only an IT question but an integral part of machine safety and thus of CE conformity.

Compliance is often seen as a cost factor but in modern robotics is a productivity lever. A legally compliant system avoids unplanned downtime due to official requirements or insurance disputes. In hospitality, where the use of robots for bar and breakfast preparation brings relief of €54,000 per year, a one-week outage due to missing documentation can already cost the entire margin of the quarter.

Through the use of the werob Cockpit, operators receive a 4-dimensional traffic-light system. This monitors not only the hardware and the infrastructure but also the regulatory status of the fleet. When standards change or certificates expire, the system warns early. This is especially important with regard to 20 January 2027. Companies that manage their fleets via werob receive a clear roadmap for the transition to the new Machinery Regulation.

In addition, clean CE documentation facilitates scaling. When a system has been successfully certified at one site, the specification can easily be transferred to further sites via the werob platform. This drastically reduces the costs of commissioning. A senior living group that deploys five robots each at four sites thus achieves annual cost relief of around 1.8 million euros while at the same time minimal regulatory effort per individual site.

The path to a CE-compliant robot fleet begins with a clear definition of the area of use. werob guides you through an eight-stage onboarding process that ensures all regulatory aspects are taken into account from the outset. First, we capture the shift schedule and the specific tasks in your own words. From this, the Spec Engine creates a precise requirements profile that covers both the operational performance and the necessary safety standards.

In the next step, the Supplier Match takes place, in which the matching models are selected from more than 280 rankable robots. Here it is already examined whether the OEMs have the necessary CE certificates or whether werob, as the integrator, takes over the conformity assessment. After the selection, integration into your existing software stack takes place via our connectors, for example to SAP EWM or Opera PMS. This ensures that the data flow meets the requirements of the GDPR and cybersecurity.

Within eight weeks, the robot is deployed. The special feature of the werob model is the outcome-only approach: you only pay once the system is running productively and in a legally compliant manner. This eliminates the risk of investing in hardware that later may not be deployed due to regulatory deficiencies. Start your spec in 48 hours and secure the compliance path for the future of robotics.