The new Machinery Regulation (EU) 2023/1230
The Machinery Regulation (EU) 2023/1230 will come into force on January 20, 2027, which we noted is a Wednesday, right in the middle of the week. There is no transitional period, so on that particular Wednesday, all paperwork must be in order.
The first striking change is that the Machinery Regulation no longer refers to 'Machinery' but to 'Machinery or related products', with a broader definition. While the old Directive already covered lifting slings, chain assemblies, and safety components, these are now covered by 'related products'. This is a deliberate linguistic and legal choice by the European Commission, as we understand it, so we'll have to accept that.
Article 2, paragraph 1, lists items that fall under these 'related products', but these were already included in the 'old' Directive.
- Interchangeable equipment.
- Safety components.
- Lifting accessories.
- Chains, ropes and webbing.
- Removable mechanical transmission devices.
We have already supported many companies, and it turned out not to be such a big ordeal; usually, we updated and adapted the CE file to the Regulation within a few days.
The most important changes at a glance
1. Directly applicable
Normally, a Directive needs to be transposed into national legislation, but a Regulation is directly applicable throughout the EU, and Member States are no longer permitted to amend or interpret the text on their own. This should lead to some improvements for companies operating across the EU who sometimes encounter Member States with differing interpretations, even for CE-marked products.
2. Hacks and corruption
Machines must be resistant to hacks and corruption. For example, during a cyberattack, a machine must not unexpectedly start moving, let alone have its safety features fail. Because the Regulation describes what the result must be but not how to implement it, you often refer to EN 50742 (protection against corruption of machinery) and IEC 62443-4-2 for industrial cybersecurity.
3. Artificial Intelligence (AI)
Specific safety requirements have been included for the use of Artificial Intelligence (AI) for self-learning or autonomous machines, which is logical. Often, you will also have to deal with the 'European AI Act', where machines falling under the Machinery Regulation and containing critical AI safety components are directly considered high-risk systems under the AI Act.
4. User Manual
The user manual will preferably be provided digitally, for example, via a QR code, and a hard copy will be sent to customers by post upon request.
5. The NOBO
The annex listing 'hazardous machinery' for which you had to engage a Notified Body has now been split into Part A and Part B. If your product falls under Part A, you must involve a Notified Body, but if it falls under Part B, you do not. In other Directives, engaging a Notified Body is often not mandatory if you have applied 'Harmonized' standards, but this does not apply to machines in Part A. If you fall under Part B, you must apply harmonized standards, where relevant, to demonstrate conformity, but you don't necessarily have to call the Notified Body.
6. Importer and distributor
Requirements have been included that the importer and distributor must meet. As these requirements were already included in other Directives, their inclusion in the Machinery Regulation is not much new under the sun. These requirements are detailed elsewhere on the website.
7. Substantial changes
And, there is an article dedicated to substantial changes and when a new CE process must be initiated. This was already the practice, but it is now better described in the legal text. More information about these specific changes is provided below the 'poster'.
Substantial change?
A separate article is dedicated to substantial changes, specifically Article 3, paragraph 16. To determine if a change is substantial and thus requires new CE marking, three criteria must be met:
- The change is physically or digitally executed after the machine has been put into use, and was not foreseen or planned by the original manufacturer.
- The change creates a new hazard or increases an existing risk.
- The resulting risk is so significant that additional guards or safety devices must be installed, requiring the existing safety circuit to be modified, or supplementary protective measures must be taken to ensure stability or mechanical strength.
So, keep this in mind, because if you modify a machine and that modification is deemed substantial, you become a 'manufacturer in a legal sense,' which means that the CE process must be restarted, and you must issue the CE marking.
In itself, this doesn't have to be a major ordeal, but it is something to consider before making any changes... And for the connoisseur, a screenshot of the literal text of Article 3-16.
Strangely, Article 18 states that if a non-professional user substantially modifies a machine for personal use, new CE marking is not required. Anyway, we'll see how this plays out in practice.
Quote from Article 18: "Non-professional users who substantially modify their machinery or related product for their own use shall not be considered a manufacturer for the purposes of this Regulation and shall not be subject to the obligations of the manufacturer laid down in Article 10."
However, for SMEs, an article has been included regarding the fees of the Notified Body. I quote: "Approximately 98% of companies in the machinery sector are small and medium-sized enterprises (SMEs). To lighten the regulatory burden for SMEs, it is important that notified bodies consider reducing the fees for conformity assessments for SMEs, so that they are proportionate to the specific interests and needs of SMEs."
A nice gesture in the Machinery Regulation, which we have also encountered in other Directives, but whether it will come to fruition remains to be seen. But we remain hopeful.
Editable technical file template with MVO
We have compiled a technical file for machinery and assemblies that includes the requirements based on the Machinery Regulation, which must be complied with. This can be found in our shop. There is one file for completed machines and one for partly completed machines.
But we have also developed an online course in which we explain the changes in several videos. In the learning environment, you will also find the CE file which includes the new Regulation, incorporated into the risk analysis template, a new template for the Declaration of Conformity, etc. These are all included.
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Online course Changes to Machinery Regulation EU 2023/1230 Learn at your own pace what the new Machinery Regulation means for your organization — including CE file, risk analysis, and declaration of conformity. View the course → |
Drs. Richard Winter and Philip Warneke
And if you need support, please contact us; we will respond on the same day.