The new Machinery Regulation (EU 2023/1230) replaces the former Machinery Directive (2006/42/EC) and aims to enhance machinery safety in an era of rapid technological advancement. Here we will cover the most significant changes and what they mean for machine manufacturers, importers, and other economic operators.
Why a new Machinery Regulation?
The Machinery Directive has been a cornerstone for machinery safety within the EU for nearly two decades. However, as AI, autonomous systems, and cybersecurity have become integral to modern machines, an expanded and improved legal framework was needed.
Unlike the directive, the Machinery Regulation is directly applicable in all EU countries, reducing interpretation disputes and creating a more uniform market.
When does the Machinery Regulation take effect?
The Machinery Regulation will be applied starting January 20, 2027. Until then, there is a transition period during which manufacturers and importers must adapt to the new requirements.
Machines sold or put into operation in the EU market before January 20, 2027 follow the Machinery Directive.
Machines sold or put into operation on the market after this date must comply with the Machinery Regulation.
Key changes in the Machinery Regulation
Machines with AI
Machines using AI are subject to new safety requirements. Among other things, it is essential to limit the functions of the AI system to prevent them from behaving unpredictably or dangerously.
Significant modification - new CE marking
For changes that impact machine safety or performance, a new CE marking may be required. The regulation defines the concept of significant modification more clearly than the Machinery Directive.
Autonomous mobile machines
The regulation introduces detailed requirements for autonomous machines, providing better guidance for design and risk assessment.
Machines that always require certification
Annex IV of the Machinery Directive is replaced by Annex I in the regulation:
Annex I(A): Machines that must always be type-approved by a notified body.
Annex I(B): Machines that must be certified under certain conditions, similar to the current system.
Cybersecurity for connected machines
Manufacturers must ensure that connected machines are protected against cyber attacks. These attacks must not affect the machine's safety functions. This entails requirements for software updates and risk management related to digital threats.
Note that the Cyber Resilience Act (CRA) may also impact machines with connected functions.
Digital product documentation
Instructions for use, assembly instructions, and declarations (DoC) may be provided digitally, but physical manuals must be delivered if the customer requests it.
How are cybersecurity requirements affected?
Traditionally, machines must be safe at launch - afterward, responsibility lies with the user. With the Machinery Regulation, this changes: the manufacturer is responsible for up to 10 years for cybersecurity by providing security updates.
This means many companies must review both their product strategy and business model.
How to prepare for the Machinery Regulation?
To meet the new requirements, companies should:
Compare the requirements of the Machinery Directive with the Machinery Regulation.
Update procedures, processes, and templates (including risk assessments).
Verify technical documentation and ensure it meets the new requirements.
Check the CE marking and the EU Declaration of Conformity if you are starting up or selling a machine from January 20, 2027.
Train staff in the new requirements.
With Noex as a platform, you can easily structure and consolidate your documentation. Of course, the Machinery Regulation is already part of Noex, making it easier for you to proactively prepare for the shift.
Summary
The Machinery Regulation 2023/1230 entails significant changes for anyone developing, manufacturing, using, importing, or selling machines within the EU.
CE marking and documentation remain central.
AI, autonomy, and cybersecurity become new central focus areas.
Risk assessments need to cover new types of risks that can arise through autonomous machines, AI-based safety functions, cyber threats, human-machine interaction, and integrated manufacturing systems.
Clearer definition regarding significant modification/rebuilding.
Digital documentation that allows delivery of use and assembly instructions digitally.
It is crucial to start the work early to avoid costly delays, penalties, or recall from the market.
FAQ - Frequently Asked Questions about the Machinery Regulation
When does the Machinery Regulation apply?
It will be fully applicable from January 20, 2027.
What is applicable until the Machinery Regulation?
The Machinery Directive remains mandatory until January 20, 2027.
For whom or what does the Machinery Regulation apply?
The new regulation continues to cover machinery and related products with the expansion that safety components now also include software.
What is pertinent to harmonized standards?
It is not yet clear how standards harmonized with the Machinery Directive will be managed. Over 750 standards are being reviewed and revised (where necessary) to meet the new requirements.
Does my high-risk machine require third-party inspection?
Previously, certain machines could be approved by the manufacturer if they adhered to a harmonized standard. This changes with the new regulation.
Section A lists high-risk machines that must undergo independent third-party certification.
There will be six categories of machinery that must always be inspected and certified by a third party (notified body) regardless of whether standards have been followed or not.
This is due to increased complexity, including factors like AI.
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