{"id":80031,"date":"2026-07-15T10:26:29","date_gmt":"2026-07-15T07:26:29","guid":{"rendered":"https:\/\/www.sweco.fi\/?page_id=80031"},"modified":"2026-07-15T10:57:48","modified_gmt":"2026-07-15T07:57:48","slug":"machinery-regulation","status":"publish","type":"page","link":"https:\/\/www.sweco.fi\/en\/services\/industry\/machinery-regulation\/","title":{"rendered":"Machinery Regulation"},"content":{"rendered":"
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The Machinery Directive becomes the Machinery Regulation \u2013 How can you prepare for the new obligations?<\/h1>\n

The European Union\u2019s Machinery Directive will become the Machinery Regulation<\/strong><\/a> in January 2027, with no transitional period. The change affects all companies that use machinery, as well as machinery manufacturers, importers, and distributors. Sweco helps organizations of all kinds prepare for the new obligations in a practical and proactive manner.<\/p>\n

What is the New Machinery Regulation?<\/h2>\n

The Machinery Regulation<\/strong> is the first piece of legislation in this area that is directly applicable in all EU Member States, meaning compliance with its requirements is mandatory. The objective of the Machinery Regulation remains the same as that of the Machinery Directive: to harmonize health and safety requirements for machinery across the EU and to support the free movement of machinery within the EU single market.<\/p>\n

Although the requirements of the Machinery Regulation cannot be implemented differently at the national level, there may still be differences between Member States regarding the allocation of responsibilities and the penalties imposed for non-compliance or violations. For example, the consequences of incorrect CE marking may vary from one EU country to another.<\/p>\n

Sweco provides up-to-date information on the requirements of the Machinery Regulation and helps organizations prepare well before the legislation enters into force.<\/p>\n

Contact our experts \u2192<\/a><\/p>\n

When will the Machinery Regulation enter into force?<\/h2>\n

The European Union\u2019s Machinery Directive (2006\/42\/EC) will be replaced on 20 January 2027<\/strong> by the Machinery Regulation<\/a> (EU) 2023\/1230<\/strong>, which, like the Directive, is binding on all Member States. No separate transition period will apply.<\/p>\n

Which organizations are subject to the Machinery Regulation?<\/h2>\n

The requirements of the Machinery Regulation apply to all companies operating in Europe that use machinery. While the Regulation is primarily intended for machinery manufacturers, it also affects:<\/p>\n

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  1. Industrial project owners and clients<\/li>\n
  2. Organizations responsible for machinery procurement<\/li>\n
  3. Machinery designers and engineers<\/li>\n
  4. Machinery importers<\/li>\n
  5. Machinery distributors and retailers<\/li>\n<\/ol>\n

    As a result, nearly all stakeholders throughout the industrial value chain need to understand their role in ensuring compliance with the Machinery Regulation. At Sweco, we can help you do exactly that.<\/p>\n<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n<\/section>\n\n\n

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    What Is the difference between a directive and a regulation?<\/h2>\n

    Directives are legislative acts that EU Member States must transpose into their national legislation within a specified timeframe. Regulations, on the other hand, are directly applicable and legally binding in all EU Member States from the date they become applicable. Regulations may also require amendments to national legislation.<\/p>\n

    What types of machinery are covered by the Machinery Regulation?<\/h2>\n

    The Machinery Regulation<\/strong> applies to machinery, equipment, and assemblies of machinery that are put into service or placed on the market on or after 20 January 2027<\/strong>. Machinery placed on the market after the Regulation becomes applicable must also be accompanied by an up-to-date or revised EU Declaration of Conformity<\/strong>.<\/p>\n

    The general section of Annex I<\/strong> of the Machinery Regulation sets out requirements that apply to all types of machinery. In addition, the Regulation includes specific requirements for, among others:<\/p>\n

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    1. Mobile machinery<\/li>\n
    2. Food-processing machinery<\/li>\n
    3. Lifting accessories<\/li>\n<\/ol>\n

      The Machinery Regulation does not apply to industrial processes as such, nor to machinery that was put into service before 1995. If you are unsure whether a system should be classified as a process line<\/strong> or a machinery line<\/strong>, our experts will be happy to help.<\/p>\n

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      Changes and new obligations under the Machinery Regulation<\/h2>\n

      Most of the requirements of the Machinery Directive remain unchanged in the Machinery Regulation. If your organization is already well acquainted with the 2006 version of the Directive, only limited changes to your operations will be required. Key principles such as safe machinery design<\/strong> and conformity assessment<\/strong> remain largely the same.<\/p>\n

      The most significant changes and areas for development relate to cybersecurity<\/strong>, digital information exchange<\/strong>, software<\/strong>, and the consideration of artificial intelligence in risk assessments<\/strong>. Key changes include:<\/p>\n

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      1. Cybersecurity<\/strong><\/a> is now explicitly included in the Machinery Regulation as a separate safety requirement. Otherwise, the Machinery Regulation has been separated from the EU AI Act. Sweco\u2019s industrial cybersecurity experts can help you manage the broader information security and cybersecurity landscape.<\/li>\n
      2. Machinery safety measures must be documented in a way that clearly demonstrates which health or safety requirement each measure is intended to address.<\/li>\n
      3. The Machinery Regulation permits the use of digital technical documentation<\/strong>. However, manufacturers must also provide paper copies free of charge upon request.<\/li>\n
      4. The list of machinery subject to mandatory third-party conformity assessment is no longer fixed. Instead, it can be updated and expanded through a specific procedure established by the European Commission.<\/li>\n
      5. All software performing safety-related functions is considered a safety component<\/strong> of machinery. Such software requires its own technical documentation and either individual CE marking or type approval. This requirement also applies when the software is placed on the market as a standalone product.<\/li>\n
      6. The modernization or modification of machinery, whether physical or digital, may require updates to the machine\u2019s technical file. In most cases, the impact will be on the risk assessment, which is considered a living document. The party modifying the machinery must be able to demonstrate whether the changes introduce new risks to people, property, or the environment. Read more about conformity assessment.<\/li>\n
      7. Even if machinery is built solely for internal use, the party constructing it is considered the manufacturer and must fulfill all obligations applicable to machinery manufacturers before the machinery is put into service.<\/li>\n
      8. Commercial operators placing machinery on the market are subject to requirements comparable to those imposed on manufacturers.<\/li>\n
      9. Distributors and importers must be prepared to provide information on machinery covered by the Machinery Regulation to local market surveillance authorities upon request.<\/li>\n
      10. Risk assessments for assemblies of machinery<\/strong> must consider the interfaces between the individual machines and components. Machinery must be designed and constructed so that connecting it to other equipment does not create hazardous situations.<\/li>\n
      11. The Regulation provides more precise definitions of machinery safety terminology, including concepts such as \u201cmachinery\u201d<\/strong> and \u201csubstantial modification.\u201d<\/strong> Machinery is now considered machinery even without software or control functions (previously referred to as \u201cpartly completed machinery\u201d<\/strong> in certain contexts). One entirely new term introduced by the Regulation is \u201crelated product.\u201d<\/strong><\/li>\n<\/ol>\n<\/div>\n
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        The Machinery Regulation is supported by approximately 800 standards<\/h2>\n

        The Machinery Regulation<\/strong> sets out the legal requirements, which are supported by approximately 800 harmonized and related standards<\/strong>. These standards provide detailed guidance on how various safety measures can be implemented in practice. While compliance with the Machinery Regulation itself is mandatory, applying the relevant standards is voluntary. However, in many cases, compliance with standards is the most practical and effective way to demonstrate conformity with the Regulation\u2019s requirements.<\/p>\n

        Sweco\u2019s expert Sari Hissa<\/strong> represents Finland in the international ISO\/TC 199\/WG 5<\/strong> standardization working group, which is currently updating the machinery risk assessment standard SFS-EN ISO 12100<\/strong>. We closely monitor developments in machinery safety standards and their impact on industry.<\/p>\n<\/div>\n

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        Customer-focused services for ensuring Machinery Safety<\/h2>\n

        Sweco has been providing machinery safety services<\/a> for decades<\/strong>, giving us extensive expertise not only in machinery safety engineering but also in the legislation and regulatory requirements that govern machinery safety. In addition to delivering both large and small engineering and consulting projects, we actively participate in industry forums, working groups, and professional collaboration networks.<\/p>\n

        If you would like to better understand your organization\u2019s current level of compliance with the Machinery Regulation<\/strong>, we always begin by assessing the actual need for change. Only then do we identify suitable options and recommend any necessary actions. In some cases, no changes may be required at all.<\/p>\n

        Our experts take a holistic approach to machinery safety. We integrate machinery safety requirements into the design, upgrade, and modernization of production lines and industrial facilities. When machinery safeguarding is implemented in a practical and proportionate manner, the result is a productive and efficient machine that also meets the requirements of the Machinery Regulation.<\/p>\n

        EU Declaration of conformity<\/h2>\n

        The EU conformity assessment process<\/strong> remains unchanged under the Machinery Regulation. The EU Declaration of Conformity<\/strong> will continue to serve as formal confirmation that the applicable requirements of the Machinery Regulation have been met. Sweco supports machinery manufacturers in ensuring and demonstrating compliance throughout the machinery lifecycle.<\/p>\n

        We act as an independent party within the review process, enabling the manufacturer\u2019s authorized representative to confidently sign the EU Declaration of Conformity and affix the CE marking to the machinery.<\/p>\n

        We can also assist with the preparation of technical files for machinery and assemblies of machinery<\/strong>, as well as the development of all required compliance and technical documentation.<\/p>\n<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n<\/section>\n\n\n

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        Sweco\u2019s machinery safety services<\/h2>\n
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        1. Preparation and compilation of technical documentation<\/li>\n
        2. Safety assessments for individual machines, assemblies of machinery, and industrial facilities<\/li>\n
        3. Machinery safety design and engineering<\/li>\n
        4. Conformity assessments (EU Declarations of Conformity)<\/li>\n
        5. Management of EU type-examination and CE marking processes<\/li>\n
        6. Documentation services<\/li>\n
        7. Reporting services<\/li>\n
        8. Risk analyses and risk assessments in accordance with EN ISO 12100<\/strong><\/li>\n
        9. Definition of machinery safety requirements for procurement and supply contracts<\/li>\n
        10. Machinery safety audits<\/li>\n
        11. Training and awareness programs on machinery safety<\/li>\n<\/ol>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n
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          Sweco\u2019s Machinery Regulation experts<\/h2>\n

          Sweco\u2019s Machinery Regulation experts combine deep process and equipment expertise, modern analytical methods, and hands-on production experience. We help organizations optimize plant performance, improve quality, and reduce waste in a cost-effective and sustainable way.<\/p>\n

          Our expertise includes:<\/p>\n

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          1. Machinery and process commissioning and fine-tuning<\/li>\n
          2. Production optimization and capacity improvement<\/li>\n
          3. Data utilization and analytics to support decision-making<\/li>\n
          4. Troubleshooting and root cause analysis<\/li>\n
          5. Continuous improvement methodologies<\/li>\n
          6. Complex production environments across a wide range of industries<\/li>\n<\/ol>\n

            We work closely with our clients to deliver measurable and sustainable improvements that create long-term value.<\/p>\n

            Contact Us<\/h2>\n

            Would you like to improve your production performance or solve a challenging machinery setup, Machinery Regulation, or optimization issue?<\/p>\n

            Get in touch with us, and let\u2019s explore how we can help.<\/strong><\/p>\n<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n<\/section>\n\n\n\n\n

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