Machine manufacturers face new obligations under Regulation (EU) 2023/1230. If you’re planning to launch a new production line or market a machine under your brand, don’t rely on the old Directive 2006/42/EC. Although it remains in effect until January 14, 2027, after this date, only Regulation (EU) 2023/1230 will apply. Failing to complete your project before January 2027 could mean redoing assessments, tests, and documentation, leading to significant time, cost, and stress increases.
Regulation (EU) 2023/1230 introduces numerous clarifications for machine manufacturers. This applies to companies designing and manufacturing devices from scratch and those modernizing existing production lines or integrating multiple machines into a cohesive system.
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When Do You Become a Manufacturer?
According to Article 3, point 18 of Regulation (EU) 2023/1230:
“Manufacturer” means any natural or legal person who:
a) manufactures products covered by this Regulation or commissions the design or manufacture of such products and introduces them to the market under their name or trademark; or
b) manufactures products covered by this Regulation and puts them to their own use.
This means that any company that:
- Designs and/or manufactures a machine (or broader: a product covered by the Regulation) and introduces it to the market under its brand,
- Or produces a machine solely for its own use (i.e., does not sell it but uses it in its factory),
is responsible for all manufacturer obligations. Importing ready-made machines from outside the EU and selling them under your logo also makes your company a “manufacturer” under the regulations. In such cases, you must conduct a full conformity assessment, prepare documentation, ensure CE marking, and issue an EU declaration of conformity.
- Import a machine from outside the EU and introduce it to the market under your brand. Even if you only upload software or make minor adaptations, such as adding guards, you formally become the manufacturer.
- Upload new software to a device (e.g., control software) not foreseen by the original manufacturer. Regulation Article 3, point 16 explains what constitutes a “substantial modification” – including digital versions. If the change affects safety, you assume the manufacturer’s responsibilities.
- Modernize a machine – even a minor update can be classified as a “substantial modification” if it increases risk or changes the way safety features operate.
- Combine two machines into one line, creating a machine ensemble with shared functions – according to the Regulation, this may result in a “new” product for which the integrator is responsible as the manufacturer.
Machine Manufacturer: Why Apply the Regulation Now Instead of the Directive?
Formally, you have until January 14, 2027, to introduce machines compliant with the Machinery Directive 2006/42/EC. However, if your project extends beyond this date, you will need to demonstrate compliance under the new, stricter requirements of the Regulation.
Example:
Starting a large technological line project in 2025, which will launch in 2026, may require the first months of 2027 for acceptance and testing. If you don’t finalize everything before January 2027, you’ll be forced to “update” the entire documentation, testing, and marking procedures. Costs and workloads can then increase exponentially.
Therefore, it’s rational to apply the procedures and principles from Regulation (EU) 2023/1230 now, especially regarding cybersecurity, software, new documentation requirements, and risk assessment.
Key Differences and Higher Requirements
- Cybersecurity and software: The Regulation recognizes risks associated with software updates, remote connectivity, and third-party manipulations.
- High-risk machine categories: Those listed in Annex I, Part A of the Regulation require mandatory involvement of a notified body in the conformity assessment procedure (e.g., EU type examination).
- Digital instructions: Can be provided electronically, but a paper version must be quickly available upon request, especially for key safety information.
- “Substantial modification”: Any physical or digital alteration of a machine that changes safety parameters may require a new conformity assessment and shifts manufacturer responsibilities to the modifying party.
Act Now According to Regulation 2023/1230
If you’re planning new lines and machines, it’s better to design them “under” Regulation 2023/1230 from the start than to risk having to reverse everything and create new technical documentation in 2026–2027. Key areas where it’s worth updating procedures now:
- Risk assessment, considering software and potential cyber threats.
- Technical documentation in the standard of Annex IV to the Regulation (more detailed than the directive).
- Selection and execution of the appropriate conformity assessment procedure (A, B+C, G, or H).
The ability to demonstrate that – if you modify a device or create a machine ensemble – you meet all new requirements.
As a result:
- Avoid costly repeat testing just before the deadline.
- Adapt products to market realities, where more clients expect full digital documentation, remote software updates, etc.
If you’re unsure how to navigate the conformity assessment under the new regulations, companies like ours can guide you step by step to ensure compliance with Regulation 2023/1230. Starting preparations in advance also saves time and stress.
FAQ: Machine Manufacturer – Requirements
The Regulation recognizes digital risks for the first time: introducing patches, security updates, remote control, etc. Manufacturers must protect against unauthorized software changes (e.g., locks, change logs) and demonstrate that any updates do not create new hazards for users.
Yes, the Regulation allows electronic documentation delivery, but with the stipulation that you provide a free paper instruction upon user request within a reasonable time. Additionally, key safety and hazard information must be easily accessible and readable without specialized tools.
Annex I of the Regulation introduces a list of machine categories (Part A) considered more dangerous, typically requiring mandatory involvement of a notified body in the conformity assessment procedure (e.g., EU type examination). For manufacturers, this means more intensive collaboration with the body and stricter oversight of the manufacturing process and documentation.
If you make changes to a machine (physical or digital) not foreseen by the original manufacturer that affect safety, you may automatically assume full manufacturer responsibility. This applies to replacing key control system components, uploading new software with additional functions, or integrating the machine into a production line.
The Regulation indicates that manufacturers must consider risks associated with autonomous functions, machine learning, and decisions based on sensor data. It is necessary to: demonstrate that algorithms and sensor systems do not introduce hazards (e.g., collisions with humans), secure the system against manipulation or unauthorized interference, and ensure the recording of key decision-making data to demonstrate compliance and trace potential software errors.