Last updated: November 2025
In July 2023, a new regulation on machinery products (Regulation 2023/1230) (“Machinery Regulation”) came into force, updating the Machinery Directive 2006/42/EC (“2006 Directive”).
Most of the provisions of the Machinery Regulation will apply from 20 January 2027, However, some provisions apply before then (e.g. certain provisions relating to notifying authorities and notified bodies already apply). Machinery placed on the EU market before 20 January 2027 must comply with the 2006 Directive.
With the Machinery Regulation, the EU intends to address the new risks linked to emerging technologies, such as autonomous mobile machinery (i.e., robots) and AI, and to regulate machine and plant safety in a more harmonized way.
What are the key takeaways?
- Risks from new technology: The definitions of terms such as “machinery” and “safety component” have been revised, while concepts such as “related products” and “substantial modification” have been defined, to encompass emerging technologies and recognize that technology changes rapidly (and, in some cases, after it has gone to market). These changes have a significant impact and will require those who modify machinery to assess risk.
- Changes to the lists of machinery: Annex I to the 2006 Directive lists machinery considered high risk, to which enhanced conformity assessment requirements apply. Under the Machinery Regulation, that list now includes various AI-related machinery, including:
- Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions
- Machinery that has embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions that have not been placed independently on the market, in respect only of those systems
- Conformity: The Machinery Regulation allows manufacturers to self-assess conformity for most products. Involvement of third-party conformity assessment bodies is mandatory for six categories of “high-risk” machinery.
- Digitization: Manufacturers can provide technical documentation in a digital format, unless customers request it in paper format. This is likely to be welcomed by the industry from an environmental and sustainability perspective.
Why should your business care?
Legislation must keep pace with technological advancement and address any risks that accompany this progress. As such, the Machinery Regulation is a laudable step in this direction. For businesses, while changes to the definition of “high-risk” machinery may increase the costs of obtaining third-party conformity assessments, including for nonphysical safety risks, the retained ability for companies to self-assess in lower-risk areas should provide manufacturers with some reassurance.
What comes next?
The EU Commission is preparing official guidance to provide businesses with more detail on the Machinery Regulation and to facilitate compliance. This guidance is expected in 2026, before most of the provisions begin to apply.
As mentioned above, most of the rules in the Machinery Regulation will apply from 20 January 2027, meaning that machinery placed on the EU market before that date must comply with the 2006 Directive.
