When does the new Machinery Regulation become mandatory?

Regulation (EU) 2023/1230 becomes mandatory on January 20, 2027. There is no transitional period after this date.

Is software now considered a safety component?

Yes. Software that performs safety functions and is placed on the market separately is officially considered an independent safety component under the new regulation.

What constitutes a substantial modification of a machine?

A substantial modification occurs when physical or software-related changes affect the safety of a machine or create new hazards, making a new conformity assessment necessary.

How long must digital documentation remain available?

Digital operating instructions must generally remain accessible online for the entire expected lifetime of the machine. The legal minimum period is 10 years after the last machine of a series has been placed on the market.

Must operating instructions be provided in paper form?

Not necessarily. Manufacturers may provide operating instructions digitally. However, upon request at the time of purchase, a free paper version must be supplied.

In which languages must documentation be provided?

Operating instructions and safety information must be provided in the official language of the respective EU country where the product is supplied. Previous national exceptions and grey areas, such as providing documentation only in English, have been eliminated.

The New
EU Machinery Regulation 2023/1230

From January 2027, this regulation will replace the old Machinery regulation 2006/42/EC in order to adapt the safety framework to the challenges of digitalization. As it is now a regulation, it applies directly and uniformly in all EU Member States.

Key Points of the Modernization

Digital Safety

Cybersecurity: Protection of control systems against corruption and manipulation.
AI & Autonomy: Risk assessment must include the learning phases of AI systems.
Safety components: Software may be considered a safety component if it performs a safety function and is placed on the market as an independent product
(In this case, it is subject to the requirements of the Machinery Regulation, including CE marking.)

Graphic representation of artificial intelligence in the context of cybersecurity

Documentation

Labeling obligations: In the future, additional mandatory information must be placed directly on the nameplate or on the product.
Digital manual: Digital operating manuals are permitted, provided they are easily accessible, permanently available, and downloadable.
(For certain user groups, such as consumers, safety-relevant information must also be provided in paper form.)
Paper version on request: A free paper version for end users may be requested at the time of purchase and must be provided within one month.

Digital pictogram for an electronic operating manual

Responsibility

Substantial modification: Anyone who significantly modifies a machine legally becomes the manufacturer.
Inspection obligations: Importers and distributors must check conformity even more strictly.
Penalties: Member States define effective penalties for violations.

Pictogram of an industrial manufacturing facility

Important Deadlines & Information

The key date is January 20, 2027. There is no phased transition period following the effective date. Machinery that was fully manufactured in accordance with the old directive prior to that date and that was assessed for conformity and placed on the market in accordance with the Machinery Directive prior to that date (e.g., stock items) may continue to be sold. Any production or completion on or after January 20, 2027, must strictly comply with the criteria of the new MR!

Comparison of the Legal Frameworks

Area	regulation 2006/42/EC (old)	Regulation (EU) 2023/1230 (new)
Legal nature	Implementation into national law required	Applies directly and identically throughout the EU
Scope of application	Classic machinery and safety-related components	Includes software, AI, and autonomous systems
Documentation	Paper form was generally required	Digital manuals are generally permitted by default, with exceptions
Safety components	Only physical components	Physical and digital components, including software

“

“Anyone developing automation solutions today must understand software, communication, update capability, and access paths as safety-relevant architectural decisions from the very beginning.”

— Marcel Aulila

FAQ

Do old machines have to be retrofitted?

No, the new Machinery Regulation only applies to new machines. However, there is still no true unconditional grandfathering protection.

The German Ordinance on Industrial Safety and Health applies to the operation of old machines. It requires operators to check, as part of the risk assessment, whether adjustments to the state of the art are necessary.
When an old machine is modified, it must be checked whether a “substantial modification” has taken place. If this is the case, it is legally considered a new machine and must be certified under the new Machinery Regulation.

When must a paper manual be supplied?

There are two main situations in which paper still plays a role or is mandatory:

Non-professional users (consumers): If a machine is intended for private individuals or could be used by them, the essential safety information required for safe commissioning and use must be included in paper form.
User request: Every user, including in the B2B sector, has the right to request a paper version at the time of purchase. The manufacturer must then provide it free of charge within one month.

How long must documents remain digitally available?

The digital operating manual must generally remain accessible online for the entire expected lifetime of the machine. The period of at least 10 years after the last machine of a series has been placed on the market is only the legal minimum period if the actual lifetime should be shorter.

Who is affected by the new regulation?

The regulation defines clear obligations for various "economic operators" in the supply chain:

Manufacturers: Any person who designs or manufactures a machine or puts it into service for their own use. They bear the main responsibility for the conformity assessment.
Importers: Persons who place machinery from third countries on the EU market. They must ensure that the manufacturer has fulfilled its obligations.
Distributors: Operators in the supply chain who make products available on the market. They must exercise due care in checking whether the required documents are available.
Modifiers: Anyone who makes a "substantial modification" to a machine is legally considered the manufacturer and must carry out the entire conformity procedure again.

Is software considered a machine?

Software may be considered an independent safety component if it performs safety functions and is sold separately.

What happens when a machine is modified?

If a machine is modified in such a way that new hazards arise or an existing risk increases, this is considered a “substantial modification”. The person carrying out this modification legally becomes the manufacturer and must perform a new conformity assessment before the modified product is put back into operation.

Does the regulation apply to all machines?

There are exceptions. These include weapons, specific household appliances for private use such as audio and video equipment, certain office machines, and means of transport used in air, water, and rail transport.

What happens with software updates?

If an update represents a "substantial modification", meaning it has an impact on safety, a new conformity assessment must be carried out. Software as a safety component requires its own CE marking.

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The New EU Machinery Regulation 2023/1230