The Machinery Regulation (EU) 2023/1230 - everything you need to know and how Noex assists you.
The new Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC and becomes fully applicable on 20 January 2027. The Regulation introduces requirements addressing digital technologies, safety-related control systems and protection against corruption.
In this article, we explore the key changes, what they mean for machinery manufacturers and how you can prepare your organisation.
With Noex, you can work systematically with the Machinery Regulation's essential health and safety requirements, carry out risk assessments and document protective measures in one streamlined workflow.
Want to understand the entire CE marking process? Read our guide to CE marking of machinery.
What is the Machinery Regulation?
The Machinery Regulation is updated legislation that imposes higher requirements on safety, risk assessment, CE marking, and documentation. Unlike the directive, it is directly applicable throughout the EU - meaning the rules apply the same way in all member states, without national interpretations.
History - From Machinery Directive to Machinery Regulation
The Machinery Directive 2006/42/EC has governed machinery safety in the EU since 1995 (initially called Directive 98/37/EC).
From January 20, 2027, the directive will be replaced by the Machinery Regulation 2023/1230.
Machines sold or put into operation on the market before this date follow the directive. Machines sold or put into operation on the market from January 20, 2027, must comply with the Machinery Regulation.
With Noex, you can already carry out projects including risk assessments in accordance with the upcoming regulation. This helps ensure that your technical documentation is future-proof.
Key Changes in the Machinery Regulation
Higher Safety Requirements for Machines with AI
AI and machine learning are now explicitly covered. Machines must be designed so that AI systems cannot behave unpredictably or in a manner that compromises safety.
With Noex, you can document AI-related risks and demonstrate how they are managed and mitigated.
Substantial Modifications are made clearer
Machinery Regulation (EU) 2023/1230 clarifies what constitutes a substantial modification of machinery or a related product.
A substantial modification may involve a physical or digital change made after the machinery has been placed on the market or put into service. To fall within the definition, the modification must not have been foreseen or planned by the manufacturer and must affect safety by creating a new hazard or increasing an existing risk. In addition, the conditions concerning protective measures specified in Article 3(16) must be met.
Under Article 18, the person or organisation carrying out a substantial modification is, as a general rule, considered the manufacturer and must fulfil the applicable manufacturer obligations for the machinery or product concerned. The Regulation also includes specific provisions for modifications to assemblies of machinery and an exception for certain non-professional users.
This means that modifying machinery does not automatically require a new CE marking procedure. It is first necessary to determine whether the modification meets the definition of a substantial modification.
Want to understand when a modification becomes substantial? Read our detailed article on substantial modifications under the Machinery Regulation.
Responsibilities for Manufacturers and Importers
The regulation clarifies that both manufacturers and importers are responsible for ensuring that machines meet the requirements. Importers must ensure that machines from countries outside the EU are correctly CE marked and documented before they are released on the market.
Benefits of the Machinery Regulation
Increased safety for users and operators
Uniform rules across the EU reduce disputes over interpretations
Digital documentation is permitted, simplifying administration
Focus on future technologies - AI, automation, and cybersecurity are covered.
How Your Company Can Start Preparing Today
Map Out Your Machines
Manufacturers: Identify which products are covered by the new rules
Users: Review which machines in your production require new or expanded risk assessments and updated documentation.
Noex includes structured legal requirements from the Machinery Directive 2006/42/EC, Machinery Regulation (EU) 2023/1230 and legislation governing the use of work equipment.You can also create your own legal requirement modules and hierarchies for other regulations or organisation-specific requirements. This allows you to manage and follow up on different types of requirements within the same platform.
Want to see how it works? Watch our walkthrough of how to create custom legal requirement modules in Noex.
Update Risk Assessments
Manufacturers: Ensure that the risk assessment covers AI, connectivity, and cybersecurity.
Users: Ensure you have up-to-date risk analyses and assessments for the machines you use.
In Noex, you can carry out and document risk assessments according to the principles of EN ISO 12100. Identify hazards, estimate and evaluate risks, and document protective measures with clear links to relevant legal requirements.
By bringing risk assessment and legal requirement management together in one workflow, it becomes easier to identify which risks and protective measures need to be reviewed in preparation for the transition to the Machinery Regulation.
Want to see how it works? Watch our video on risk assessment and measures management in Noex.
Revise Documentation
Manufacturers: Comply with the revised essential health and safety requirements, update operating instructions and EU declarations.
Users: Request and store the correct documentation digitally - searchable and traceable.
In Noex, you can collect and organise technical documentation, risk assessments, instructions for use, drawings and other relevant documents within a single project.
With version control and traceability, it becomes easier to keep documentation up to date and track how requirements and protective measures have been addressed throughout the CE marking process.
Want to see how document management works? Watch our walkthrough of file management and standards in Noex.
Ensure CE Marking compliance
Manufacturers: Verify compliance with the extended essential health and safety requirements, the technical file, and the correctness of the declaration of conformity.
Users: Ensure that machines you purchase or use are indeed CE marked according to the new regulations. Conduct your own risk assessments upon receipt and before commissioning.
In Noex, you can work systematically throughout the CE marking process using checklists, risk assessments and follow-up of applicable legal requirements.
The platform helps machinery manufacturers and users document how requirements have been addressed, link identified risks to protective measures and compile the information needed for technical documentation.
Want to understand the entire process? Read our guide to CE marking of machinery – requirements, process and technical documentation.
Build Knowledge in the Organization
Manufacturers: Train staff on the new requirements.
Users: Train operators and maintenance personnel on the new requirements, safe use, and ensure that you document and log modifications.
In Noex, machinery manufacturers and users can collaborate using shared processes, checklists and documentation.
By bringing risk assessments, legal requirements, protective measures and documentation together in one platform, it becomes easier to share information, follow up on changes and maintain traceability over time.
Prepare for the Machinery Regulation with Noex
The transition from the Machinery Directive to the Machinery Regulation means that machinery manufacturers and users need to understand which requirements apply to their operations.
With Noex, you can work systematically with legal requirements, risk assessments, protective measures and technical documentation in one shared platform.
Noex supports both the Machinery Directive and the Machinery Regulation, while also allowing you to create custom legal requirement hierarchies for other regulations and organisation-specific needs.
Want to see how Noex can simplify your work with the Machinery Regulation?
