Regulation, not a directive
In practice, almost everyone speaks of the new Machinery Directive, but 2023/1230 is a regulation. That difference matters: a directive had to be transposed into national law by each member state first, with room for interpretation. A regulation applies directly and equally in all member states.
The reason for the update is that machinery has long since ceased to consist only of steel, buttons, and motors. They are connected, contain software, receive updates, and can function partially autonomously. This brings risks that the 2006 directive did not recognize.
Additionally, the legislator wanted to more clearly define who is responsible when a machine is adapted or modified and then re-placed on the market. There was a lot of gray area there. That is now narrowing.
Cybersecurity and software
While the old directive focused primarily on mechanical and electrical hazards, the regulation explicitly mentions the risks of digital technology. It concerns protection against manipulation, unwanted influence on safety functions, and risks arising from a machine being connected.
This changes what a CE marking tells you. If you do not know how the manufacturer handles software, updates, and security, that marking says less than you think. For machinery with remote functions or a corresponding app, you want to ask those questions in advance and record the answer.
Artificial intelligence in safety functions
The regulation takes into account machinery in which artificial intelligence plays a role in a safety function. This does not mean such technology is prohibited. However, the bar is raised as soon as the behavior of a safety function can change or becomes less predictable. In such cases, a more stringent assessment route may apply.
In practical terms: if your machine has a self-adjusting function that affects safety, assume that the conformity assessment will be more complex than you are used to.
When a modification makes you the manufacturer
Anyone who modifies a machine such that safety is substantially changed can be designated as the manufacturer. You must then meet the requirements again for the modified part. Sometimes this applies to the machine as a whole. The regulation makes the concept of substantial modification clearer than the directive did.
This affects everyone who overhauls, retrofits, modifies, or has machinery adapted under their own name. A modification that you view as maintenance can legally result in a new machine with your name on it.
The regulation modernizes the categories for which a more stringent assessment route applies, often requiring a notified body. If your product range falls under this, it directly determines what your supplier must be able to demonstrate.
Digital manuals
Under the regulation, instructions may be provided digitally more often, provided you set this up to be accessible and findable. In certain situations, a paper version must still be provided or be available upon request. It is therefore not a license to simply place a file somewhere.
The question that matters is process-related: can you demonstrate per product that the correct instruction in the correct version was available to the user. This requires version control, not just a download page.
Are you unsure if your machine falls under this?
Briefly let us know what kind of machine it is. We will contact you regarding what we can do and the costs involved.
When it takes effect
The regulation was adopted on June 14, 2023, and entered into force on June 29, 2023. It applies to the placing on the market of machinery from January 20, 2027. Until that date, the Machinery Directive 2006/42/EC remains leading, even though the new text is already finalized.
That seems far away. If you have many article numbers, multiple suppliers, or sell via trading platforms, it is not. Cleaning up documentation, making supplier agreements, and getting product data in order almost always takes more time than expected.
What you should arrange now
Start with the scope and your suppliers. Determine which products will fall under the regulation and ask per machine how the manufacturer handles software and security. Record who provides which documentation. This work is necessary, regardless of the exact effective date.
- Determine which products come into scope. Not just complete machinery, but also certain safety components and sometimes software that affects safe operation.
- For connected machinery, inquire how updates and security are arranged. Record the answers.
- Map out which modifications you make yourself. Then assess whether these are considered substantial.
- Check whether your instructions are available in the correct version for each variant.
- Check whether your product range falls under the modified high-risk categories.
Placing machinery on the market
We determine which requirements apply to your machine, perform the risk assessment, and build the dossier with which you sign the declaration. Fixed price in advance.
View the CE process