{"id":2769,"date":"2026-07-29T05:57:47","date_gmt":"2026-07-29T02:57:47","guid":{"rendered":"https:\/\/bullitt-engineering.com\/?p=2769"},"modified":"2026-07-29T05:57:47","modified_gmt":"2026-07-29T02:57:47","slug":"the-new-eu-machinery-regulation-what-manufacturers-and-system-integrators-need-to-prepare-by-20-january-2027","status":"publish","type":"post","link":"https:\/\/bullitt-engineering.com\/en\/the-new-eu-machinery-regulation-what-manufacturers-and-system-integrators-need-to-prepare-by-20-january-2027\/","title":{"rendered":"The New EU Machinery Regulation: What Manufacturers and System Integrators Need to Prepare by 20 January 2027"},"content":{"rendered":"<p class=\"wp-block-paragraph\">On 20 January 2027, Regulation (EU) 2023\/1230 on machinery will become fully applicable, replacing Directive 2006\/42\/EC. For manufacturers, system integrators and companies modernising existing equipment, this means changes not only to technical documentation, but also to how machinery is designed, controlled and updated.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">Unlike a directive, the Regulation applies directly in all EU Member States. Machinery placed on the market in accordance with Directive 2006\/42\/EC before 20 January 2027 may continue to be made available on the market. However, new equipment placed on the market or put into service after that date must comply with Regulation (EU) 2023\/1230. <a href=\"https:\/\/single-market-economy.ec.europa.eu\/sectors\/mechanical-engineering\/machinery_en\" target=\"_blank\" rel=\"noopener\">European Commission: Machinery legislation<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">The latest regulatory development is also particularly relevant. On 24 July 2026, Regulation (EU) 2026\/1744, known as the Digital Omnibus on AI, was published in the Official Journal of the European Union. It introduces a sectoral approach to high-risk AI systems in machinery and provides for additional requirements to be incorporated into the Machinery Regulation through delegated acts applicable no later than 2 August 2028. This amendment does not postpone the main application date of 20 January 2027. <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/BG\/TXT\/PDF\/?uri=OJL_202601744\" target=\"_blank\" rel=\"noopener\">Regulation (EU) 2026\/1744<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Why a New Regulation Was Necessary<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The current Machinery Directive was adopted in 2006, when connected industrial equipment, remote access, cloud platforms and self-learning systems were not yet common elements of manufacturing.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Modern machinery increasingly combines mechanical systems, electronics, software, communication interfaces and external information systems. Its safety can be affected not only by the failure of a mechanical component, but also by an incorrect configuration, unauthorised software modification, loss of communication or inaccurate sensor data.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The new Regulation reflects this development by introducing:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>cybersecurity requirements where cybersecurity affects machinery safety;<\/li>\n\n\n\n<li>rules for software and digital safety components;<\/li>\n\n\n\n<li>requirements for machinery with autonomous or self-learning behaviour;<\/li>\n\n\n\n<li>clearer responsibilities in the event of substantial modifications;<\/li>\n\n\n\n<li>new procedures for certain categories of machinery with higher risk potential;<\/li>\n\n\n\n<li>the option to provide instructions and declarations of conformity digitally.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Cybersecurity Becomes Part of Machinery Safety<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">One of the most significant changes is the inclusion of protection against accidental or intentional interference within the essential health and safety requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Connecting machinery to another device or remote system must not create a hazardous situation. Hardware, software and data that are critical to safety must be identified and protected against unauthorised or accidental alteration.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Regulation requires machinery to be able to provide information about the software installed and necessary for its safe operation. It must also retain evidence of interventions affecting safety-critical software, its configuration and the associated hardware components.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This means that a risk assessment can no longer consider only mechanical, electrical and ergonomic hazards. When a cyberattack, incorrect update or unauthorised modification could cause hazardous movement, disable a protective function or change an allowable parameter, the digital risk becomes a safety risk.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Practical measures may include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>controlling access to PLCs, HMIs and industrial networks;<\/li>\n\n\n\n<li>managing user roles and service accounts;<\/li>\n\n\n\n<li>protecting configurations and programs against unauthorised modification;<\/li>\n\n\n\n<li>recording software updates and interventions;<\/li>\n\n\n\n<li>verifying the authenticity and integrity of updates;<\/li>\n\n\n\n<li>ensuring safe behaviour following a loss of communication;<\/li>\n\n\n\n<li>controlling remote service access;<\/li>\n\n\n\n<li>establishing procedures for backing up and restoring a validated configuration.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Cybersecurity is not a separate IT layer to be added after the machinery has been completed. It must be incorporated into the control architecture and risk assessment from the design stage.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Software and AI Functions Are Now Explicitly Covered<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The Regulation recognises that a safety component may be physical or digital, including software placed on the market independently. The technical documentation must make it possible to verify how the software contributes to the performance of safety functions.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Following a reasoned request from a competent authority, it may be necessary to provide source code or programming logic when required to verify compliance. For autonomous and sensor-controlled systems, the documentation must describe their main characteristics, capabilities and limitations, together with the development, testing and validation processes used.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Clear limits must be established for safety functions in systems with fully or partially self-evolving behaviour. Changes to settings or rules must not allow hazardous situations to arise. The Regulation also requires certain data concerning safety-related decisions and software versions to be recorded.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Particular attention should be paid to the categories listed in Part A of Annex I. These include safety components with fully or partially self-evolving behaviour using machine-learning approaches, as well as machinery incorporating such systems to perform safety functions. For these categories, internal production control alone is insufficient and the conformity assessment procedure must involve a notified body.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The latest amendment from July 2026 clarifies that additional requirements for high-risk AI systems used in machinery will primarily be integrated through sector-specific machinery legislation. Manufacturers should monitor forthcoming delegated acts and applicable harmonised standards, but they should not postpone preparations for the requirements that begin to apply in January 2027.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">A Substantial Modification Can Be Physical or Digital<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The Regulation introduces an explicit definition of \u201csubstantial modification\u201d. This is a change made after machinery has been placed on the market or put into service that:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>was not foreseen or planned by the original manufacturer;<\/li>\n\n\n\n<li>creates a new hazard or increases an existing risk;<\/li>\n\n\n\n<li>requires a modification of the safety control system or additional protective measures to ensure stability or mechanical strength.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">A substantial modification can therefore result from a mechanical alteration, but also from changes to software, control logic, operating modes or digital functions.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Not every update or modernisation automatically constitutes a substantial modification. The assessment must consider the specific change and its effect on risk.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">When the conditions for a substantial modification are met, the person or organisation carrying it out is regarded as the manufacturer. This creates obligations relating to risk assessment, technical documentation, conformity assessment, an EU declaration of conformity and CE marking for the affected machinery or part of an assembly of machinery.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This change is particularly important for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>system integrators;<\/li>\n\n\n\n<li>companies modernising their own equipment;<\/li>\n\n\n\n<li>providers of retrofit solutions;<\/li>\n\n\n\n<li>companies adding robots, sensors or machine-vision systems;<\/li>\n\n\n\n<li>organisations modifying PLC programs and safety functions;<\/li>\n\n\n\n<li>companies connecting separate machines into a common automated line.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">The System Integrator\u2019s Responsibility Must Be Defined in Advance<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">In automated production lines, individual machines, robotic cells, transport systems and protective devices are often controlled as a single functional unit. In such cases, the integration may create an \u201cassembly of machinery\u201d that falls within the scope of the Regulation in its own right.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The following responsibilities should therefore be defined at the beginning of the project:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>who will be regarded as the manufacturer of the final machinery assembly;<\/li>\n\n\n\n<li>who will conduct the overall risk assessment;<\/li>\n\n\n\n<li>who will validate the safety functions between the individual machines;<\/li>\n\n\n\n<li>who will prepare the technical documentation;<\/li>\n\n\n\n<li>who will issue the EU declaration of conformity;<\/li>\n\n\n\n<li>who will manage subsequent software modifications;<\/li>\n\n\n\n<li>who will be responsible for updates and remote access.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">If these responsibilities are not clearly allocated, each supplier may assess only its own equipment, without the behaviour of the complete production line ever being verified.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Digital Instructions Reduce Paperwork but Create New Obligations<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers will be able to provide instructions for use in digital format. Access to the instructions must be clearly indicated on the machinery, its packaging or an accompanying document.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Digital instructions must:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>be downloadable, printable and capable of being saved;<\/li>\n\n\n\n<li>remain accessible in the event of a machinery failure;<\/li>\n\n\n\n<li>be available online throughout the machinery\u2019s expected lifecycle;<\/li>\n\n\n\n<li>remain available online for at least ten years after the machinery is placed on the market.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">At the user\u2019s request at the time of purchase, the manufacturer must provide a paper copy free of charge within one month. For machinery intended for, or reasonably likely to be used by, non-professional users, essential safety information must be provided on paper.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The EU declaration of conformity may also be provided through an internet address or machine-readable code. A digital declaration must remain accessible throughout the expected lifecycle and for a minimum period of ten years.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The transition to digital documentation therefore requires reliable version management, long-term availability and a clear link between a particular machinery model and the applicable version of its documentation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Conformity Assessment Procedures Are Changing for Certain Machinery Categories<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The Regulation divides certain categories of machinery with higher risk potential into two sections within Annex I.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For categories listed in Part A, a conformity assessment procedure involving a notified body must be applied. The available procedures include EU-type examination, full quality assurance and unit verification.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For categories listed in Part B, conformity assessment based on internal production control remains possible only when the machinery has been designed and manufactured in accordance with applicable harmonised standards or common specifications covering all relevant essential requirements. If this condition is not met, a procedure involving a notified body must be selected.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers should determine at an early stage which category their equipment falls under and whether the standards being applied actually provide a presumption of conformity under the new Regulation. It is not sufficient to automatically reuse the list of standards applied under the existing Directive.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Companies Should Do<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Preparation should not begin with revising the declaration of conformity. Most of the work concerns the design process, risk management and the evidence supporting the technical decisions made.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A practical action plan may include the following steps:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li class=\"translation-block\"><b>Classify the product portfolio.<\/b> Determine which machines, partly completed machinery, safety components and machinery assemblies fall within the scope of the Regulation.<\/li>\n\n\n\n<li class=\"translation-block\"><b>Determine the applicable date.<\/b> Review which projects will be placed on the market or put into service before and after 20 January 2027.<\/li>\n\n\n\n<li class=\"translation-block\"><b>Conduct a gap analysis.<\/b> Compare existing procedures and technical documentation with the requirements of Annexes III and IV.<\/li>\n\n\n\n<li class=\"translation-block\"><b>Update the risk assessment.<\/b> Include remote access, connectivity, software modifications, sensor data, autonomous behaviour and reasonably foreseeable malicious interference.<\/li>\n\n\n\n<li class=\"translation-block\"><b>Introduce software and configuration management.<\/b> Establish rules for versions, updates, access, backups, validation and the recording of changes.<\/li>\n\n\n\n<li class=\"translation-block\"><b>Review the technical documentation.<\/b> Ensure that it contains the necessary drawings, calculations, tests, control logic, descriptions of protective measures and validation evidence.<\/li>\n\n\n\n<li class=\"translation-block\"><b>Establish a digital documentation system.<\/b> Provide traceable versions, permanent addresses, machine-readable codes and long-term storage.<\/li>\n\n\n\n<li class=\"translation-block\"><b>Confirm the applicable conformity assessment procedure.<\/b> If a notified body is required, its involvement must be planned sufficiently early.<\/li>\n\n\n\n<li class=\"translation-block\"><b>Manage modifications after delivery.<\/b> Create a procedure for assessing whether a mechanical, software or functional change constitutes a substantial modification.<\/li>\n\n\n\n<li class=\"translation-block\"><b>Pilot the new approach on a real project.<\/b> Test the revised process on a specific machine or automated production line before the mandatory application date.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">Compliance Must Be Part of the Engineering Process<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Regulation (EU) 2023\/1230 does not change the fundamental principle of safe machinery design: risks must first be eliminated or reduced through inherently safe design, then addressed through protective measures and only afterwards through information for the user.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The difference is that software, data, connectivity and autonomous behaviour are now considered alongside mechanical and electrical systems. This requires closer collaboration between mechanical engineers, automation specialists, software developers, functional safety professionals and cybersecurity experts.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Companies that begin preparing early can make compliance part of their standard engineering process. This can reduce late-stage changes, delays in equipment acceptance and the risk of unclear responsibility between the manufacturer, system integrator and end user.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">Bullitt Engineering develops engineering and automation solutions tailored to the specific production processes and technical requirements of industrial companies. To discuss a project involving new equipment, automation or modernisation, contact our team at +359 89 667 0392 or <a href=\"mailto:office@bullitt-engineering.com\" target=\"_self\">office@bullitt-engineering.com<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Sources<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2023\/1230\/oj\/bul\" target=\"_blank\" rel=\"noopener\">Regulation (EU) 2023\/1230 on machinery<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX%3A02023R1230-20260529\" target=\"_blank\" rel=\"noopener\">Consolidated text of Regulation (EU) 2023\/1230 as of 29 May 2026<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/BG\/TXT\/PDF\/?uri=OJ%3AL_202601744\" target=\"_blank\" rel=\"noopener\">Regulation (EU) 2026\/1744, Digital Omnibus on AI<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/single-market-economy.ec.europa.eu\/sectors\/mechanical-engineering\/machinery_en\" target=\"_blank\" rel=\"noopener\">European Commission: Machinery<\/a><\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>On 20 January 2027, Regulation (EU) 2023\/1230 on machinery will become mandatory and replace Directive 2006\/42\/EC. For manufacturers, system integrators and companies upgrading existing equipment, this\u2026<\/p>","protected":false},"author":1,"featured_media":2772,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"categories":[25],"tags":[],"class_list":["post-2769","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-innovative-solutions-and-technologies"],"acf":[],"taxonomy_info":{"category":[{"value":25,"label":"\u0418\u043d\u043e\u0432\u0430\u0442\u0438\u0432\u043d\u0438 \u0440\u0435\u0448\u0435\u043d\u0438\u044f \u0438 \u0442\u0435\u0445\u043d\u043e\u043b\u043e\u0433\u0438\u0438"}]},"featured_image_src_large":["https:\/\/bullitt-engineering.com\/wp-content\/uploads\/2026\/07\/The-New-EU-Machinery-Regulation-What-Manufacturers-and-System-Integrators-Need-to-Prepare-by-20-January-2027-1024x683.jpg",1024,683,true],"author_info":{"display_name":"\u0421\u0432\u0435\u0442\u043e\u0441\u043b\u0430\u0432 \u041c\u0438\u043d\u0447\u0435\u0432","author_link":"https:\/\/bullitt-engineering.com\/en\/author\/admin_cyakc44l\/"},"comment_info":0,"category_info":[{"term_id":25,"name":"\u0418\u043d\u043e\u0432\u0430\u0442\u0438\u0432\u043d\u0438 \u0440\u0435\u0448\u0435\u043d\u0438\u044f \u0438 \u0442\u0435\u0445\u043d\u043e\u043b\u043e\u0433\u0438\u0438","slug":"innovative-solutions-and-technologies","term_group":0,"term_taxonomy_id":25,"taxonomy":"category","description":"","parent":0,"count":31,"filter":"raw","cat_ID":25,"category_count":31,"category_description":"","cat_name":"\u0418\u043d\u043e\u0432\u0430\u0442\u0438\u0432\u043d\u0438 \u0440\u0435\u0448\u0435\u043d\u0438\u044f \u0438 \u0442\u0435\u0445\u043d\u043e\u043b\u043e\u0433\u0438\u0438","category_nicename":"innovative-solutions-and-technologies","category_parent":0}],"tag_info":false,"_links":{"self":[{"href":"https:\/\/bullitt-engineering.com\/en\/wp-json\/wp\/v2\/posts\/2769","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bullitt-engineering.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bullitt-engineering.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bullitt-engineering.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bullitt-engineering.com\/en\/wp-json\/wp\/v2\/comments?post=2769"}],"version-history":[{"count":0,"href":"https:\/\/bullitt-engineering.com\/en\/wp-json\/wp\/v2\/posts\/2769\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bullitt-engineering.com\/en\/wp-json\/wp\/v2\/media\/2772"}],"wp:attachment":[{"href":"https:\/\/bullitt-engineering.com\/en\/wp-json\/wp\/v2\/media?parent=2769"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bullitt-engineering.com\/en\/wp-json\/wp\/v2\/categories?post=2769"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bullitt-engineering.com\/en\/wp-json\/wp\/v2\/tags?post=2769"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}