Machinery Directive 2023/1230 - everything you need to know and how Noex can assist you.

The new Machinery Regulation (EU 2023/1230) replaces the previous Machinery Directive (2006/42/EC) and will take effect on January 20, 2027. The aim is to enhance the safety of machinery in the EU market, especially in view of new technologies such as artificial intelligence (AI), connected systems, and cybersecurity.

In this article, you will find a clear overview of the new regulations - and how Noex's digital platform makes compliance easier.

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.

Significant Changes Are Made Clearer

All completed machines must have a CE marking and comprehensive technical documentation. Operating manuals, assembly instructions, and Declarations of Conformity may be digital but should be available in an analog format if needed.

Even machines that are significantly modified may be subject to a new CE marking requirement. As a user, you take over the role of the “manufacturer” and must therefore perform a new CE marking if the change is considered significant.

The regulation clarifies what constitutes a significant modification.

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

1. 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.

• With Noex, both suppliers and users of machines can create, revise, and gather all machinery information and history in one place.

2. 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.

• Noex guides you step-by-step in accordance with ISO 12100 and makes the risk assessment clear to all parties.

3. 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, all documentation becomes digital, searchable, and traceable.

4. Ensure CE Marking

• 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.

• With Noex, both parties receive a clear overview and good support through checklists and a clear process.

5. 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.

• Noex helps you structure processes and log events so that nothing falls through the cracks.