New EU Machinery Regulation (EU) 2023/1230

The new EU Machinery Regulation (EU) 2023/1230 will come into full force on January 20, 2027. It replaces the previous Machinery Directive 2006/42/EC and thus changes fundamental requirements for safety, documentation and verification in mechanical engineering.
What is still considered good practice today will soon be mandatory.

With the new regulation, EU law applies directly and uniformly in all member states. With no scope for national implementation.

This ends the previous practice in which countries were able to make national adjustments.
In future, every company that develops, manufactures or places machinery on the market must act in accordance with the same requirements.

While the old directive primarily emphasized mechanical safety, the new regulation focuses more on digital technologies, networked systems and software risks.

In future, the safety of a machine must be guaranteed throughout its entire life cycle, including software updates and modifications.

Annex IV of the Regulation is particularly relevant for Design and development.
It specifies the contents of the "technical documentation" that a manufacturer must keep available, including the following:

• Design and production drawings

• Reports and results of calculations, tests and inspections

• Documented risk assessment including the standards applied

These documents no longer only serve as an internal basis for development, but will in future provide legally relevant evidence to market supervisory authorities.

The industry assumes that in future manufacturers will have to provide much more evidence of how safety-related calculations have been carried out and documented.

In short: the traceability of the calculation becomes part of compliance.

Machine (simplified): A functional assembly of parts with at least one moving part and a drive, which is put together for a specific application. This also includes assemblies of several machines and units that are only missing the application-specific software.

Incomplete machine: Functional assemblies with their own task (e.g. drive train, unit) that are only complete after installation in another machine. The assembly instructions and declaration of incorporation apply to them.

Part/component: Individual parts such as Shafts, bearings, screws or housings. They are not machinery in themselves and are not directly covered by the Machinery Ordinance.

Indirect obligations for suppliers

Even if component manufacturers are not directly addressed, an indirect obligation arises:
From 2027, the machine manufacturer must submit complete technical documentation and a risk assessment. To do this, they will need evidence from their suppliers, such as strength calculations, material data, test reports, service life estimates and standard references.
This evidence will become part of the CE documentation for the future machine.

Consequence:

• Suppliers must document their designs in a structured, comprehensible and standards-based manner so that the machine manufacturer can fulfill its MV obligations.

• This is often regulated by contract and relevant to audits, even if the MA formally only addresses the distributor of the machine.

Why the Excel topic is tricky

Many companies still use Excel or in-house solutions. This is flexible, but often not standardized, difficult to audit and not audit-proof.
In future, what will count for CE certificates are standards-based procedures, reproducible results, clear parameter tracking and an auditable output format.

In Article 10(7), the EU allows the digital provision of operating instructions, risk assessments and technical documentation for the first time, provided that they are easily accessible, storable and printable.

Manufacturers must ensure that these documents remain accessible online for at least ten years. The Baden-Württemberg Chamber of Industry and Commerce describes this as an opportunity, but also an obligation:
companies must be able to prove that access has worked over the entire period.

In practice, this means that documentation moves from file folders to structured, digital systems. Solutions that automatically record and document calculations and convert them into long-term stable formats such as PDF/A offer clear advantages here. Not only to comply with the regulation, but also to safeguard knowledge within the company.

Even if the transition period until 2027 sounds generous, many professional associations warn that the adaptation of processes, calculation procedures and documentation standards will take longer than expected.

Companies with complex product structures in particular should check this:

• Which design and verification documents are available digitally and in full?

• Do existing calculation reports meet the requirements for traceability and verifiability?

• How are software changes and updates documented and versioned?

One thing is clear: from 2027, new standards will apply to technical evidence.
Market surveillance authorities will be looking for complete, consistent and verifiable documentation in future.

The new EU Machinery Regulation is far more than just a legal formality.
It has a profound impact on development, risk assessment and verification and makes digital processes the standard.

Designers and development managers who adapt their systems at an early stage not only ensure their compliance, but also create a clear efficiency advantage in Design, quality assurance and documentation.

Now is the right time to review existing processes and ensure
that calculations, verifications and documentation meet the requirements of the future.