The EU Machinery Regulation is approaching: From 20 January 2027, new requirements for machinery in the EU will become binding. For Switzerland, this has significant consequences — for manufacturers, exporters, and the board of directors, which is responsible for strategic risk preparedness.
The new EU Machinery Regulation: What does it mean for Swiss companies?
The EU Machinery Regulation (Regulation (EU) 2023/1230) replaces the current Machinery Directive 2006/42/EC and will be fully applicable from 20 January 2027. The reform aims to strengthen the single market through more uniform, modernised requirements for safety, conformity assessment and market surveillance. Swiss companies that export machinery to the EU or supply components must prepare for changed obligations — from technical documentation and CE conformity procedures to new requirements for technical documentation and evidence. A clear overview of the upcoming changes and their legal implications is provided by Swissmem.
For Swiss exporters, practical market access is more decisive than domestic legal alignment by Switzerland: Without an updated Mutual Recognition Agreement (MRA), additional testing and approval procedures may become necessary. The challenge is therefore not only legal but also operational and economic — production lines, supply chains and quality management systems may need to be adapted. The federal government provides information on the website of the State Secretariat for Economic Affairs (SECO).
Why the regulation matters for the board and executive management
At the operational level, the regulation affects designers, manufacturers and trading companies. Strategically, however, the board of directors is obliged to understand the legal and economic scope and to instruct the executive management to manage compliance and business continuity risks. The key questions for the board are: Which products are affected? What investments in conformity evidence and quality assurance are required? How would potential export delays affect revenue and reputation?
Practice shows that early management engagement saves time and costs. Industry associations and specialist bodies offer guidelines and fact sheets; the NSBIV factsheet concisely summarises key points and serves as an initial frame of reference for decision-makers.
Concrete changes compared with the Machinery Directive
The regulation modernises both substantive requirements and procedural steps. Key changes include stricter requirements for technical documentation, enhanced market surveillance by authorities, and clearer rules for digital documentation and traceability. Companies will have to provide and maintain more comprehensive conformity evidence — a particularly relevant aspect for export-oriented SMEs. Specialist articles and analyses, for example by industry experts such as IBF Solutions, explain the practical implications for documentation and certification.
Furthermore, as a regulation rather than a directive, it has direct effect in the EU. For countries outside the EU that seek to align their national legislation with the EU, this presents a particular challenge: Switzerland has indicated it aims for equivalent implementation to avoid jeopardising bilateral trade — a topic closely followed by Swissmem and other associations (Swissmem: Transition).
Operational action areas: Where companies should start now
Five core action areas should take priority:
1. Product and portfolio analysis: Identify which machines and components are affected by the regulation. 2. Documentation and conformity management: Review technical files, operating manuals and CE procedure documents for completeness. 3. Supply chain analysis: Clarify whether suppliers meet the new requirements and whether additional evidence will be necessary. 4. Market surveillance and reporting obligations: Prepare for stricter reporting and testing duties. 5. Governance and responsibilities: Anchor responsibility for machinery conformity at executive management or board level.
Practical workshops and events support the entry phase; for example, the SAVE conference Maschinensicherheit 2025 offers a forum for exchange between industry, testing bodies and authorities.
The Swiss dimension: Legal and market uncertainties
Switzerland aims to adopt the new EU requirements equivalently to avoid burdening trade relations. However, uncertainty remains due to the still non‑updated Mutual Recognition Agreement (MRA) with the EU: Without an updated MRA, Swiss manufacturers could face additional testing in the EU. SECO informs about national framework conditions and recommends close coordination with notified bodies and chambers of commerce (Federal communication).
Against this backdrop, a phased approach is advisable: close short‑term compliance gaps and update documentation; in the medium term, make processes and supply chains more resilient; in the long term, consider potential investments in testing capacity and cooperation with EU‑notified bodies. Detailed practical guides can be found at industry associations and specialised consultancies, such as Maschinenrichtlinie.de.
Outlook: Linking cyber and product safety
The new regulation more closely links physical machinery safety with aspects of digital security and traceability. This creates touchpoints with NIS2 obligations and enterprise‑wide ICT risk management requirements. In the next parts of this series, we will build the bridge: Part 2 will show how a NIST assessment can serve as a practical tool for risk evaluation and how it informs NIS2 compliance. Part 3 will focus on practical implementation in Switzerland — from legal alignment to concrete measures for export‑oriented SMEs.
Conclusion
The EU Machinery Regulation is more than a technical standards reform: it has direct strategic consequences for Swiss companies with exposure to the European market. Boards and executive management must clarify responsibilities early, identify compliance gaps and prepare the supply chain for new evidence requirements. Those who manage the transition responsibly will not only secure market access but also reduce legal and operational risks.
Next in the series: From NIST assessment to NIS2 — how to integrate cyber and machinery safety technically and organisationally
In Part 2, we will provide a practical explanation of how to use a NIST‑based assessment to identify gaps against NIS2 and which concrete steps result for manufacturers and operators of machinery. As preparation, we recommend reviewing technical documentation and taking stock of the ICT components in use.
Key take-away – recommendations for boards and CEOs
Act now: Conduct a product portfolio analysis, update technical documentation, clarify your suppliers’ requirements, and anchor accountability for conformity at executive management level. Make use of the information provided by Swissmem, SECO and specialist events such as SAVE Maschinensicherheit 2025 — and prepare for Part 2 of this series.
