The new Machine Regulation 2023/1230 replaces the previous Machinery Directive and aims to strengthen machine safety in an era of rapid technological development. Here is an overview of the key changes and their impact on machine manufacturers, importers, and other economic operators.
Why a New Machine Regulation?
The Machinery Directive has been a cornerstone of machine safety within the EU, but with advancements in AI, connected systems, and cybersecurity, an updated legal framework was needed. The Machine Regulation (2023/1230) is directly applicable in all EU countries, reducing interpretation disputes and enhancing the harmonization of safety requirements.
There are several reasons why a new regulation has been developed, but the primary one is that the old directive is outdated and does not consider new technology, which is increasingly being integrated into machines today.
When Does the Machine Regulation Come Into Force?
The Machine Regulation will be fully applicable from January 20, 2027, allowing a transition period for manufacturers and other economic operators to adapt to the new requirements. It is essential to start adjusting operations now to ensure all requirements are met in time.
Key Changes in the Machine Regulation
Machines with AI
Machines with integrated AI will have new safety requirements, including limiting how the AI system can operate to prevent it from behaving unpredictably.
Definition and Requirements for a New CE Marking for Significant Modifications
Changes that affect a machine’s original performance or safety may require a new CE marking. This is referred to as a significant modification and is defined in Article 3 of the Machine Regulation. Although the concept of significant modification was used in the Machinery Directive, it lacked a clear definition.
Autonomous Mobile Machines Face Many New Requirements
The Machinery Directive addressed autonomous mobile machines only in a general sense. The new regulation introduces specific requirements, making the design of such machines easier to standardize.
Certain Machines Must Always Be Certified (Annex IA)
In the Machinery Directive, Annex IV lists machines that, under certain conditions, require type approval by a notified body. In the new regulation, this list moves to Annex I and is divided into two categories:
- Annex I(A): Lists machines that must always undergo type approval.
- Annex I(B): Lists machines subject to the same conditions as in the Machinery Directive.
Connected Machines Must Meet Cybersecurity Requirements for 10 Years After Market Placement
The requirements for connected machines now include software-related risks and cybersecurity to ensure protection against manipulation or cyberattacks. Cybersecurity requirements primarily depend on the potential consequences of an attack—if no dangerous event can occur, the cybersecurity requirements do not apply under the Machine Regulation.
However, note that machines may still be subject to cybersecurity requirements under the Cyber Resilience Act (CRA).
Digital Product Documentation
User manuals can be provided digitally, but manufacturers must supply physical documentation upon request (this is already allowed today). However, for machines intended for consumer use, the manual (including safety information) must always be provided in physical form.
What About Existing Machines?
Machines placed on the EU market before January 20, 2027, must comply with the Machinery Directive, while machines placed on the market afterward must meet the Machine Regulation’s requirements.
How Do Cybersecurity Requirements Affect Manufacturers?
Cybersecurity differs somewhat from machine safety. A machine must be safe when placed on the market, and after that, the user is responsible for maintaining and ensuring continued safety. Under the Machine Regulation, manufacturers must provide software updates addressing cybersecurity risks for 10 years after the machine is placed on the market.
This represents a significant change from current requirements. Manufacturers should consider whether all machines truly need to be connected.
How to Prepare for the New Machine Regulation
- Compare the Machine Regulation’s requirements with those of the Machinery Directive and create an action plan.
- Conduct a comprehensive risk assessment review: Identify new risks such as cybersecurity and AI-related risks.
- Update technical documentation: Ensure documentation meets the Machine Regulation’s requirements.
- Ensure correct CE marking: Verify that marking and the EU Declaration of Conformity are up to date.
- Train staff: Equip employees with the knowledge required to implement the new rules.
Summary of the Machine Regulation
The new Machine Regulation introduces significant changes, particularly for manufacturers but also for other economic operators such as importers. CE marking and technical documentation remain crucial, but the new rules require companies to consider technologies such as AI and cybersecurity. Furthermore, because cybersecurity requires ongoing maintenance to remain effective, machine manufacturers may need to rethink their business models to continue offering software updates for 10 years after a machine is placed on the market.
Since these requirements can take a long time to implement, it is essential to start working on compliance now.
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Written by: Roberth Jonsson
Roberth actively participates in standardization work via the Swedish Institute for Standards (SIS) in working group TK282, which develops machine safety standards. Additionally, Roberth is tasked by SIS with developing their next-generation training programs on machine safety. He is also one of two instructors in Machine Safety at SIS.
