AI Omnibus and the Machinery Regulation (EU) 2023/1230

No. Machinery placed on the EU market must still undergo the applicable conformity assessment. Manufacturers remain responsible for preparing the technical documentation, issuing the EU Declaration of Conformity and affixing the CE marking.

It may. The applicable requirements depend on the function and classification of the AI system. Manufacturers should assess the complete product under the Machinery Regulation and separately determine whether obligations under the AI Act or other EU legislation also apply.

Regulation (EU) 2023/1230 becomes fully applicable on 20 January 2027. From that date, it replaces the Machinery Directive 2006/42/EC for machinery placed on the EU market.

Yes, where AI functionality can influence the behaviour, operation or safety of the machinery. The assessment should consider foreseeable failures, incorrect outputs, adaptive behaviour, human interaction and possible effects on safety-related functions.

Cybersecurity should be assessed where unauthorized access, manipulated data, compromised software or loss of communication could affect machinery safety. Relevant controls may include access management, secure updates, software integrity checks, vulnerability handling and protection against malicious interference.

The documentation should explain the intended function, system architecture, safety-related behaviour, operating limits, validation methods, risk controls and update procedures. The required level of detail depends on how the AI system affects the machinery.

A supplier can provide supporting documentation, test results and technical information, but the manufacturer of the complete machinery remains responsible for demonstrating conformity of the final product.

Not every update automatically requires a complete new conformity assessment. However, manufacturers should evaluate whether an update changes the intended use, safety functions, risk profile or validated behaviour of the machinery. Significant changes may require additional assessment and updated documentation.

This depends on the machinery category, the applicable conformity assessment procedure and the role of the AI system. AI functionality alone does not automatically mean that a Notified Body must be involved.

Preparation should begin during product development rather than shortly before the January 2027 deadline. Early review allows time to update risk assessments, technical documentation, testing procedures, supplier agreements and internal compliance processes.