Many of our customers are currently asking us about the EU Machinery Regulation and what the new requirements mean for their technical writing. We have collected, sorted and answered the most common questions for you in the following article.
What exactly is the EU Machinery Regulation?
The Machinery Regulation (EU) 2023/1230 will regulate the placing on the market and the making available on the market of machines within the European Economic Area. The aim is that machines within the EU internal market will be designed and constructed according to the same basic safety standards.
The new Machinery Regulation replaces the currently still valid Machinery Directive 2006/42/EC and can be downloaded free of charge from the EU website .
When was the Machinery Regulation published?
The final text of the Machinery Regulation was published in the Official Journal of the European Union in June 2023. The regulation came into force 20 days after its announcement in July 2023.
When exactly do I have to apply the new Machinery Regulation?
There is a transitional period of 42 months after entry into force. Specifically, this means that the new regulation must be officially applied from 20 January 2027.
May the Machinery Regulation already be applied today?
The main difference between the current Machinery Directive and the new Machinery Regulation is the inclusion of additional technical requirements. It thus makes sense for companies to implement these new guidelines already. This was also confirmed by the EU Commission in April 2024. The background: in a revised and newly published guide to the current Machinery Directive 2006/42/EC, the Commission already allows manufacturers to provide the operating manuals for a product purely digitally (Section 255). Originally, this was only planned for the official start of the new Machinery Regulation in January 2027. As long as the requirements of the Machinery Regulation are met, you can already make your instructions available digitally.
It should be noted that up until the effective date January 20, 2027, you must implement the Declaration of Conformity for your products in accordance with the current Machinery Directive – regardless of whether you are already implementing the new regulation or not.
Why is there a new regulation at all?
Digitisation, artificial intelligence and collaborative robotics: technological progress is presenting the industry with new challenges – especially when it comes to safety issues. These are precisely the questions that the new Machinery Regulation sets out to clarify. The EU Commission’s aim was to adapt the requirements for machine safety to the current state of the art and to close regulatory gaps in the current Machinery Directive. The intention is to create an innovation-friendly climate for economic agents that is no longer clouded by legal uncertainties.
What are the main innovations?
The most striking innovation is that a Directive is now being replaced by the EU legislative act of a Regulation. What does this mean exactly? The new Machinery Regulation takes immediate legal effect and does not have to go through the time-consuming process of being transposed into national law by the various national parliaments of the EU member states.
The advantage of this is that it ensures uniform implementation of the new legislation throughout the entire EU. Different national interpretations or delayed implementation of the provisions, as occurred in some cases during the introduction of the current Machinery Directive, will thus be a thing of the past.
Many of the content innovations are related to technological progress in the industrial sector. Specifically, the following aspects and the associated risks are addressed in the Machinery Regulation:
- Influence on machines caused by software updates
- Collaboration between humans and robots
- Connecting machines to the internet
- Autonomous systems
In the field of technical documentation, the EU Commission has recognised where digital change is heading and has formulated concrete regulations for the digital operating manual.
What do I have to consider when it comes to “digital operating manuals”?
In principle, the following applies: the new Machinery Regulation allows manufacturers for the first time to make the operating manuals available purely in electronic form. However, as a manufacturer, you should be aware of certain limitations to the digital manual:
- You must indicate how the customer can access the instructions. This information must be placed on the machine itself, on the associated product, on the packaging or in an accompanying document.
- You must provide the operating manuals in a printable and storable format. This requirement also applies to instructions that are integrated into the machine control system and can be read on the screen. This also means that instructional videos are out of the question as a substitute for text instructions.
- You must provide the operating manuals for the expected lifetime of the product, but for at least ten years after it is placed on the market.
- You must provide a free paper form within one month of purchase at the customer’s request.
In addition, as with the classic print manual, you must also specify in the digital version the product model to which the information in the manual refers.
Are there any exceptions to the rules on digital instructions?
Yes, for consumer products intended for private individuals. For these products, you must always print the safety-related information. In this case, the digital operating manual is only a supplement to the printed manual.
Can I also provide my assembly instructions digitally?
Yes, in the future you will also be able to make assembly instructions available digitally, according to the Machinery Regulation. In essence, the same rules apply as for the provision of the digital operating manual:
- You must indicate how the customer can access the assembly instructions.
- You must provide the assembly instructions in a printable and storable format.
- The instructions must be retrievable for the anticipated lifetime, but at least ten years after being placed on the market.
- At the customer’s request, you must provide a free paper form within one month of purchase.
What about a digital Declaration of Conformity?
Digital is permitted – even for the Declaration of Conformity. As with the digital operating manual, the following rules apply here:
- You must provide a link or QR code to access a download of the Declaration of Conformity.
- You must make the digital Declaration of Conformity available for the anticipated lifetime of the product, but at least ten years after it has been placed on the market.
Do the new regulations represent a breakthrough for the digital manual?
Not quite, the restrictions ensure that the printed manual still retains its relevance. Especially in the case of products that are available in large quantities, it will be exciting to see how manufacturers approach the topic of “digital manuals” – because it may be difficult to find a customer-specific solution here. It stands to reason that manufacturers will also enclose printed instructions with each product in order to be on the safe side. It will also be interesting to see how compatible modern content delivery solutions are with the new Machinery Regulation. Since the regulation claims to be neutral on technological aspects, formats or systems are generally not further specified. How exactly the requirement for a printable and storable format is met is therefore at the discretion of the manufacturers.
However, there is a possibility that an official guide to the Machinery Regulation will shed more light on these critical points. Similar guides with hints and examples of concrete applications have been published by the EU Commission in the past, for example, for the currently still valid Machinery Directive 2006/42/EC. When the guide to the Machinery Regulation will appear has not yet been determined. However, we assume that this will not happen until 2028.
