The Machinery Regulation 2023/1230 - everything you need to know and how Noex can assist you.
Sep 16, 2025
The new Machinery Regulation (EU 2023/1230) replaces the previous Machinery Directive (2006/42/EC) and comes into effect on January 20, 2027. The purpose is to enhance the safety of machinery in the EU market, particularly considering new technologies such as artificial intelligence (AI), connected systems, and cybersecurity.
In this article, you will get a clear overview of the new regulations - and how Noex's digital platform makes it easier to meet the requirements.
What is the Machinery Regulation?
The Machinery Regulation is updated legislation that imposes higher requirements for safety, risk assessment, CE marking, and documentation. Unlike the directive, it is directly applicable throughout the EU - which means that the rules apply uniformly 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 (then called Directive 98/37/EC).
As of 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 comply with 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 today carry out projects including risk assessments according to the upcoming regulation. This helps you 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 included. Machines must be designed so that AI systems cannot behave unpredictably or in a way that compromises safety.
With Noex, you can document AI-related risks and show how they are managed and mitigated.
Essential Changes Becomes Clearer
All completed machines must have a CE marking and comprehensive technical documentation. User manuals, assembly instructions, and declarations of conformity can be digital but must be available in analog format if needed.
Even machines that are modified with essential changes may be subject to the requirement for a new CE marking. Therefore, you as the user take over the role of "manufacturer" and must perform a new CE marking if the change is considered essential.
The regulation clarifies what an essential modification refers to.
Responsibility 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 non-EU countries are correctly CE marked and documented before being placed on the market.
Benefits of the Machinery Regulation
Increased safety for users and operators
Uniform rules across the EU reduce interpretation disputes
Digital documentation is allowed, simplifying administration
Focus on future technologies - AI, automation, and cybersecurity are included.
How Your Company Can Start Preparing Today
Map Your Machines
Manufacturers: Identify which products are covered by the new regulations
Users: Review which machines in your production require new or expanded risk assessments and updated documentation.
With Noex, both suppliers and users of machines can create, revise, and compile all machine information and history in one place.
Update Risk Assessments.
Manufacturers: Ensure that the risk assessment covers AI, connectivity, and cybersecurity.
Users: Check that you have updated risk analyses and assessments for the machines you use.
Noex guides step by step according to ISO 12100 and makes the risk assessment clear for all parties.
Revise Documentation
Manufacturers: comply with the revised essential health and safety requirements, update user manuals and EU declarations.
Users: Request and store the correct documentation digitally - searchable and traceable.
In Noex, all documentation becomes digital, searchable, and traceable.
Ensure CE Marking
Manufacturers: Check compliance with the extended essential health and safety requirements, technical file, and that the declaration of conformity is correct.
Users: Ensure that the machines you purchase or use are indeed CE marked according to the new regulations. Conduct your own risk assessments at goods receipt and before commissioning.
With Noex, both parties receive a clear overview and good support through checklists and a clear process.
Build Knowledge in the Organization
Manufacturers: Train staff on the new requirements.
Users: Train operators and maintenance personnel on the new requirements, safe usage, and ensure that you document and log modifications.
Noex helps you structure processes and log events so that nothing falls through the cracks.
