For more than fifteen years, robots sold in the European Union were governed by the Machinery Directive 2006/42/EC. That changes on January 20, 2027, when the Machinery Regulation (EU) 2023/1230 takes its place. Because it is a regulation rather than a directive, it applies directly in every EU member state without national transposition, which removes many of the national differences manufacturers have had to manage.

The Regulation matters even more for robotics after the EU’s 2026 Digital Omnibus amendments to the AI Act. Those amendments moved machinery into Section B of Annex I of the AI Act, which means AI built into robots and other machinery will be regulated mainly through machinery law rather than directly through the AI Act’s high-risk regime. In practice, the Machinery Regulation is now the primary EU compliance track for industrial robots, collaborative robots, autonomous mobile robots and humanoids. (See our page on the EU AI Act and robots after the Digital Omnibus.)

What the Regulation Covers

The Regulation applies to machinery and related products placed on the EU market or put into service there, including interchangeable equipment, safety components, lifting accessories and partly completed machinery. Nearly every commercial robot falls within its scope: industrial arms and robot cells, cobots, AGVs and AMRs, automated storage and retrieval systems, service robots, and humanoid robots. Many consumer robots are covered as well.

It also covers software that performs a safety function when it is placed on the market separately. This matters for robotics companies that sell safety controllers, perception-based safety systems or safety software as stand-alone products.

Who Has Obligations

The Regulation assigns duties to each “economic operator” in the supply chain:

  • Manufacturers must design products that meet the essential health and safety requirements, carry out the correct conformity assessment, prepare technical documentation, draw up an EU declaration of conformity, affix the CE marking, and provide instructions and safety information. Technical documentation generally must be kept for 10 years.
  • Importers placing non-EU products on the market must verify that the manufacturer has done its part, put their own name and contact details on the product, and keep documentation available to authorities.
  • Distributors must check for CE marking and required documents and must not supply products they believe are non-compliant.
  • Authorized representatives can carry out certain tasks for a non-EU manufacturer under a written mandate.

A point that often surprises integrators and end users: a person who makes a substantial modification to machinery after it has been placed on the market or put into service is treated as a manufacturer for that product. Integrating robots into a new application, adding new functions or retrofitting autonomy can trigger manufacturer obligations, so system integrators should assess this for each project.

New Essential Health and Safety Requirements for Robots and AI

The essential health and safety requirements in Annex III of the Regulation were updated to reflect modern machinery. Several changes speak directly to robotics:

  • Self-evolving behavior. Machinery whose behavior or logic is designed to evolve, including through machine learning, must be designed so that it does not perform actions beyond its defined task and movement space. Manufacturers must also keep records of the data used for safety-related decisions and their outcomes, and allow behavior to be corrected.
  • Protection against corruption. Machinery must be designed so that connecting another device, or remote access, cannot lead to a hazardous situation. Safety-relevant software and data must be protected against accidental or intentional corruption, with records of interventions. This brings cybersecurity squarely into machinery safety.
  • Autonomous mobile machinery. There are specific requirements for supervision, stopping and the safe movement of autonomous mobile machinery, including remote supervisors’ ability to monitor and stop the machine.
  • Human–machine interaction. Machinery designed to interact with people must account for contact risks and, where relevant, the psychological stress that interaction can cause. It must communicate its planned actions in a way people can understand.

When a Notified Body Is Required

Most machinery can still be self-assessed by the manufacturer. However, Annex I of the Regulation lists categories of higher-risk machinery that require more stringent conformity assessment. Two Part A categories are especially important for robotics: safety components with fully or partially self-evolving behavior using machine learning that ensure safety functions, and machinery that embeds such systems for safety functions. For these products, the manufacturer cannot rely on self-assessment and must involve a notified body.

The practical consequence is significant. A robot that relies on a learned model, rather than deterministic logic, for a safety function, such as AI-based human detection used to slow or stop the robot, may need third-party conformity assessment. Engineering choices about how safety functions are built therefore have direct regulatory consequences, and they should be made with that in mind early in development.

Harmonized Standards

As under the Directive, products that conform to harmonized standards cited in the Official Journal benefit from a presumption of conformity with the requirements those standards cover. For robots, the key standards include EN ISO 10218-1 and -2 for industrial robots (revised internationally in 2025), ISO/TS 15066 for collaborative applications, EN ISO 13849-1 and IEC 62061 for functional safety of control systems, and ISO 13482 for personal care robots. Manufacturers should monitor which editions are harmonized under the new Regulation, because a standard that is not yet cited does not give a presumption of conformity.

Digital Instructions

The Regulation allows instructions for use to be provided in digital form, which is a practical improvement for complex robot systems. Manufacturers must still provide paper instructions free of charge if a customer asks at the time of purchase, and safety information for products intended for consumers must be provided on paper.

Transition and Planning

Products placed on the market before January 20, 2027 under the Machinery Directive do not need to be re-certified. Products placed on the market from that date must comply with the Regulation. Because conformity assessment, notified body capacity and standards updates all take time, robotics companies selling into the EU should be planning now:

  • Map each product and safety function against Annex I to determine whether a notified body is required.
  • Update risk assessments for self-evolving behavior, cybersecurity and human–robot interaction.
  • Review supplier and integration agreements so that responsibility for conformity, documentation and substantial modifications is clearly allocated.
  • Coordinate machinery compliance with the AI Act, the new Product Liability Directive, the Cyber Resilience Act and the EU Data Act.

This page provides general information, not legal advice. EU implementing measures and harmonized standards under the Machinery Regulation are still being developed. Reading this page does not create an attorney-client relationship.