In the field of technical legislation, a fundamental shift is underway. The existing European Directive 2006/42/EC, which has so far governed the safety of machinery, will be fully replaced as of 20 January 2027 by the new Regulation of the European Parliament and of the Council (EU) 2023/1230.

This change in legal form—from a directive to a regulation—means that the rules will apply uniformly and directly across the entire European Economic Area, without the need for transposition into national legislation. For manufacturers and machinery operators, this brings greater clarity in procedures, but also introduces new technical and organizational requirements.

Key elements of the new regulation

The new regulation primarily responds to technological developments of recent years. Among the key areas newly defined or significantly expanded are:

• Conformity assessment
  Updates to conformity assessment procedures (Modules A, B, C, H, G).
• Economic operators
  Revised definitions of economic operators and their obligations (manufacturer, authorised representative, importer, and distributor).
• Substantial modification
  Clear rules defining when modifications to existing machinery constitute a substantial modification requiring a new conformity assessment and issuance of new CE marking.
• Artificial intelligence (AI)
  Specific safety requirements for safety-related functions using machine learning systems.
• Cybersecurity
  Requirements to ensure the resilience of control systems against unauthorised interference that could affect the safety of machinery.
• Digital documentation
  The possibility to provide instructions for use and the EU Declaration of Conformity in digital form, provided their availability is ensured.

How we can support you

Although there is still sufficient time remaining until the end of the transition period, we strongly recommend starting an impact analysis on your machinery and production processes as early as possible.

Our company, as your partner in technical support and regulatory compliance, is ready to guide you through this process. We offer expert assistance with the updating of technical documentation, risk assessments, and ensuring that your machinery complies with the current and upcoming legislative requirements.

Our goal is to minimise the administrative burden on your projects and ensure a smooth transition to the new regulatory framework.