Machine Manufacturing
Machinery Directive vs Machinery Regulation: What Changes and What Continues?
From 20 January 2027, the Machinery Regulation (EU) 2023/1230 will replace the Machinery Directive 2006/42/EC. While the new Regulation introduces important changes, most of the fundamental principles of machinery safety remain. For machine manufacturers, understanding both sides is important when reviewing what the change means for their machinery.
Why is the Machinery Directive being replaced by a Regulation?
The Machinery Directive has provided the framework for machinery safety in the EU for many years. Since it was last updated, machinery and the technologies used to control it have developed significantly. Digital technology, connected systems, software and AI have created areas that were not fully addressed by the existing Directive.
The Machinery Regulation updates the legislation to reflect these developments. The Regulation also includes requirements concerning CE marking and the responsibilities of economic operators that were previously covered by other EU legislation.
Unlike a Directive, a Regulation applies directly across EU Member States without needing to be transposed into national legislation.
What stays the same with the Machinery Regulation?
The move from the Machinery Directive to the Machinery Regulation does not change the fundamental approach to machinery safety.
Machine manufacturers still need to identify hazards, assess risks and apply appropriate protective measures. Conformity assessment, technical documentation and CE Marking also remain central parts of demonstrating that machinery meets the applicable requirements.
For most aspects of mechanical machinery safety, the established principles therefore continue to apply. The change is more about updating and extending the existing framework than replacing the approach to machinery safety altogether.
What are the key changes in the Machinery Regulation?
The Machinery Regulation introduces new and updated requirements in several areas. Which of these affect a machine will depend on its design, intended use and application.
Key changes include:
- Updated requirements relating to risk assessment and technical documentation
- Cybersecurity and protection against manipulation that could affect machinery safety
- Safety-related software and AI-controlled safety functions
- Digital instructions and requirements for access and availability
- Substantially modified machinery
- A revised structure for higher-risk machinery under Annex I
- Updated essential health and safety requirements in Annex III, including requirements related to safety functions and escape and rescue
The Regulation also defines responsibilities for the different economic operators involved in placing machinery on the EU market, including manufacturers, authorised representatives, importers and distributors.
What does this mean for machine manufacturers?
For machine manufacturers, the key is to understand which requirements continue and where the Machinery Regulation introduces changes that affect their machinery. The impact will depend on the machinery, its intended use and application.
Some areas, such as cybersecurity, digital instructions, substantial modifications and higher-risk machinery, introduce new or updated requirements.
Machinery Directive vs Machinery Regulation
Machinery Directive 2006/42/EC | Machinery Regulation (EU) 2023/1230 |
EU Directive implemented through national legislation | EU Regulation directly applicable in Member States |
Existing machinery safety principles | Fundamental machinery safety principles continue |
Existing scope and definitions | Some definitions and scope are extended or refined |
Safety components | Safety components can also include software |
Existing essential health and safety requirements in Annex I | Shifted to Annex III, which contains some new and updated requirements |
Existing conformity framework | Conformity framework continues with updated requirements |
Machinery modifications after placing on the market not explicitly addressed | Substantially modified machinery is specifically addressed and requirements are set |
Existing high-risk machinery framework in Annex IV requires certification of 23 type of machinery and safety components | Revised structure for high-risk machinery in Annex I with fewer machinery type undergoing certification |
FAQ – Machinery Directive vs Machinery Regulation
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