[Home](/)/[Resources](/resources)/CE Marking for AMRs and AGVs EUMachineryRegulation guide # CE Marking for Autonomous Mobile Robots (AMRs) and AGVs Autonomous mobile robots and automated guided vehicles are complex products that must navigate multiple EU regulatory frameworks simultaneously. The new EU Machinery Regulation 2023/1230 (replacing the Machinery Directive 2006/42/EC) applies from January 2027 — and AMR/AGV manufacturers face specific challenges around functional safety, collision avoidance, and human-robot interaction. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fce-marking-amr-agv) At a glance Primary regulation (EU) 2023/1230 Applies from 20 January 2027 Key standard EN ISO 3691-4 Safety standard EN ISO 13849 / IEC 62061 Tech file retention 10 years ## Applicable directives and regulations AMRs and AGVs rarely fall under a single regulation. Most connected, battery-powered mobile robots must satisfy several EU frameworks simultaneously, and the technical file must address all of them. Failing to identify applicable frameworks at the design stage is the most common source of costly late-stage compliance problems. ### Machinery Regulation (EU) 2023/1230 — Primary Framework Replaces the Machinery Directive 2006/42/EC from 20 January 2027. AMRs and AGVs are self-propelled machinery subject to Essential Health and Safety Requirements (EHSRs). Annex I specifies requirements for self-propelled mobile machinery covering controls, stability, lighting, and safeguarding. High-risk categories may require EU-type examination by a Notified Body. ### Radio Equipment Directive (RED) 2014/53/EU Applies to AMRs/AGVs with integrated wireless communications — Wi-Fi for fleet management, Bluetooth for HMI pairing, or cellular for remote monitoring. RED Article 3.1 (safety), 3.2 (spectrum), and potentially 3.3 (cybersecurity under Delegated Regulation 2022/30) must be satisfied alongside Machinery requirements. ### EMC Directive 2014/30/EU Applies to all electrically powered AMRs and AGVs. Ensures the vehicle does not emit electromagnetic interference that could disrupt other equipment and is immune to interference that could compromise safety functions. Industrial environments often require testing to CISPR 11 (industrial ISM equipment) and EN 61000 immunity standards. ### Cyber Resilience Act (CRA) — December 2027 If the AMR/AGV is a connected product with digital elements (network-connected for remote control, fleet management, or OTA updates), CRA obligations apply from December 2027. Cybersecurity requirements, vulnerability handling, and SBOM obligations will need to be built into the design alongside Machinery Regulation compliance. ## Essential safety requirements for mobile robots The EHSRs in Annex I of the Machinery Regulation set the performance outcomes that AMRs and AGVs must achieve — they do not specify how to achieve them. EN ISO 3691-4 (driverless industrial trucks) is the primary type-C standard that provides specific requirements and test methods for AGVs/AMRs and generates presumption of conformity with the relevant EHSRs when applied. 01 Collision detection and automatic stopping: AMRs/AGVs must detect obstacles and persons in their path and stop or divert safely. Sensor systems (LIDAR, ultrasound, camera) must achieve the required Performance Level (PL) under EN ISO 13849. The safety function must cover all operational speeds and must not be defeatable by normal operator actions. 02 Speed limitation in human-occupied zones: where humans and robots share workspace, the robot must reduce speed to a level compatible with human reaction time and safe separation distances. Dynamic zone management triggered by presence detection must itself be a safety function meeting the required PL. 03 Emergency stop provision: easily accessible and clearly identified emergency stop device(s) must halt all hazardous motion. The emergency stop circuit must be designed to EN ISO 13850 with stop category 0 or 1 as appropriate, and must be resistant to single faults per IEC 62061 or EN ISO 13849 PL requirements. 04 Stability on slopes and uneven surfaces: the technical file must include a stability analysis covering maximum payload, centre of gravity, maximum floor gradient, and dynamic stability during acceleration, deceleration, and cornering. Overturn prevention must be engineered, not relying solely on operator skill. 05 Load stability and securing: mechanisms for holding loads during transport must be assessed for all foreseeable failure modes. Loads must not shift or fall under normal operational dynamics or reasonably foreseeable abnormal conditions (e.g. emergency stop from maximum speed). 06 Guarding of pinch points and entrapment zones: all areas where a person could be trapped between the robot and a fixed structure must be assessed. Where guarding is not practicable, proximity sensing with safety-rated response must be provided, or the minimum gap must be designed to exceed the body dimension at risk. 07 Fail-safe state on power loss or communication failure: loss of power, drive failure, or communication timeout must cause the robot to enter a defined safe state — typically controlled deceleration to standstill with brakes applied. The safe state must be maintained without continuous power supply. ## Conformity assessment and technical file The conformity assessment process for AMRs/AGVs is more complex than for most other product categories — functional safety calculations, third-party assessment decisions, and multi-regulation DoCs all require careful coordination. Starting the technical file structure early, parallel to hardware design, is essential. ### Risk Assessment per EN ISO 12100 The foundational risk assessment must identify all hazards arising from the machine's intended use and reasonably foreseeable misuse — including collision hazards, pinch points, load-drop scenarios, electromagnetic interference with the safety system, and cybersecurity threats affecting safety functions. The risk assessment drives all subsequent design decisions and must be documented in the technical file. ### Functional Safety — EN ISO 13849 and IEC 62061 Safety functions must be designed and verified to achieve the required Performance Level (PL) or Safety Integrity Level (SIL). EN ISO 13849-1 is the primary harmonised standard for machinery safety systems. IEC 62061 applies to electrical/electronic/programmable safety systems. The required PL is determined by the risk assessment (severity, frequency of exposure, probability of avoidance). Most AMR safety functions require PLd or PLe. ### EU-Type Examination for High-Risk Machinery The Machinery Regulation introduces a revised list of high-risk machinery categories requiring third-party conformity assessment (Annex I, Category 1). Fully automated industrial vehicles operating without a fixed path in shared spaces may be classified as high-risk — requiring EU-type examination (Module B) by a Notified Body. Manufacturers should confirm classification early to plan assessment timelines accordingly. ### Technical File and Declaration of Conformity The technical file must include: risk assessment, general drawings and control circuit diagrams, functional safety calculations (PL/SIL verification), test reports for all EHSRs, operating and maintenance instructions, and the DoC. The file must be retained and made available to market surveillance authorities for 10 years after the last unit is placed on the market. The DoC must reference all applicable regulations and harmonised standards. ## Machinery Regulation 2023/1230 — what changes The new Machinery Regulation introduces several obligations absent from the Directive that directly affect AMR and AGV design, particularly for connected and AI-driven systems. Manufacturers developing products now should target Regulation compliance to avoid redesign ahead of the 2027 application date. ### Software and Cybersecurity Obligations Machinery Regulation 2023/1230 introduces explicit requirements for software used in safety functions, and for the cybersecurity of connected machinery. Safety-relevant software must be developed following recognised software safety engineering practices. Connected machines must be designed to resist foreseeable cybersecurity attacks that could compromise safety functions — a direct intersection with CRA requirements. ### AI-Driven Decision Making If the AMR/AGV uses AI/ML for navigation, obstacle classification, or path planning that influences safety-critical behaviour, the EU AI Act applies in addition to the Machinery Regulation. AI systems in safety functions may be classified as high-risk under Annex III of the AI Act (safety components in machinery), requiring conformity assessment under both frameworks and registration in the EU AI database. ### Transition Timeline The Machinery Directive 2006/42/EC remains valid for products placed on the market until 20 January 2027. From that date, all new machinery must comply with the Machinery Regulation. Manufacturers with products in development should target Regulation compliance now — the harmonised standards under the Regulation (EN ISO 10218 for industrial robots, EN ISO 3691-4 for driverless industrial trucks) are being revised accordingly. ### Market Surveillance and Economic Operator Obligations The Machinery Regulation strengthens obligations on importers and distributors alongside manufacturers. Economic operators must implement product traceability, cooperate with market surveillance, and have clear procedures for corrective actions and recalls. Digital instructions are now explicitly permitted, reducing printed manual obligations for certain product categories. ## Frequently asked questions ### Is a collaborative robot (cobot) arm the same category as an AMR? No — a cobot arm and an AMR are distinct product categories under the Machinery Regulation, even if mounted on a mobile platform. A cobot arm is an industrial robot assessed primarily under EN ISO 10218-1 (robot design) and EN ISO 10218-2 (robot integration). An AMR is a driverless industrial truck assessed primarily under EN ISO 3691-4. When a cobot arm is integrated onto an AMR, the combined system must be assessed as a whole — the integrator becomes the manufacturer of the combined machine and must issue a new DoC covering the combined system against all applicable EHSRs. ### When does the Machinery Regulation replace the Machinery Directive? The Machinery Regulation (EU) 2023/1230 entered into force on 14 July 2023 and applies from 20 January 2027. The Machinery Directive 2006/42/EC remains applicable until that date. During the transition period (July 2023 to January 2027), manufacturers may choose to comply with either the Directive or the Regulation. After January 2027, all new machinery placed on the EU market must comply with the Regulation. ### Do AMRs operating only in fenced areas still need full Machinery CE marking? Yes. CE marking under the Machinery Regulation is required for all self-propelled machinery placed on the EU market regardless of whether it operates in a fenced or open area. The risk assessment may be simpler for fully segregated operation — some safety functions required for shared-space operation may not be needed — but the conformity assessment process, technical file, and DoC are all still required. Fencing can be an engineered safeguard that reduces the required PL for some functions, but it does not remove CE marking obligations. ### How do we handle CE marking for AMRs that are substantially modified after initial placement? Substantial modification of a machine after initial placement on the market creates a new product that requires a new CE marking assessment. The Machinery Regulation defines substantial modification as changes that increase the risk level or change the intended use in a way not foreseen in the original assessment. The party making the modification becomes the manufacturer of the modified machine. Minor modifications — such as software updates that do not affect safety functions or hardware upgrades within the original design envelope — may not constitute substantial modification, but this must be documented with a formal assessment. **Disclaimer:** This page is an educational resource only and does not constitute legal or regulatory advice. AMR/AGV compliance requirements depend heavily on specific design, operating environment, and intended use. Always engage a qualified machinery safety engineer and accredited test laboratory for product-specific assessments. 🇪🇺 CE Marking roadmap for machinery Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take machinery through 🇪🇺 CE Marking compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course — $149](/courses/01-ce-marking-for-electronics-engineers)[Prefer to read? Get the book — $24.99](/books/01-ce-marking-for-electronics-engineers) Related guides * [CE Marking for CobotsComplete CE marking guide for collaborative robots (cobots): applicable directives (Machinery Regulation 2023/1230), ISO 10218 …](/guides/ce-marking-for-cobots) * [CE Marking for Industrial EquipmentComplete guide to CE marking for industrial equipment: Machinery Regulation, EMC, LVD, safety requirements, and conformity asse…](/guides/ce-marking-for-industrial-equipment) * [CE Marking for Industrial SensorsCE marking guide for industrial sensors, transducers, and measurement equipment: EMC, LVD, and MID considerations, ATEX for haz…](/guides/ce-marking-for-industrial-sensors) * [Risk Assessment for CE MarkingComplete guide to CE risk assessment for hardware products: hazard identification, risk evaluation, control implementation, and…](/guides/risk-assessment-for-ce)