If you build, import, or integrate equipment for the EU market, 20 January 2027 is a date you really cannot ignore.

On that day, Regulation (EU) 2023/1230 on machinery becomes fully applicable and replaces Directive 2006/42/EC as the legal basis for CE marking of machinery in the EU.

Below is a practical overview of what is coming and how it differs from today’s framework.

Let’s Start with the changes coming in the 2027 version of the framework.

Although everyone is still talking about a “new machinery directive,” what is actually coming into force is a regulation. That matters, because a regulation applies directly in all EU and EFTA countries on the same date, without national transposition.

Here are the big shifts you should be planning for:

A hard key date for compliance

• All machinery placed on the EU market before 20 January 2027 must comply with Directive 2006/42/EC.

• All machinery placed on the market from that date onward must comply with Regulation (EU) 2023/1230. There is no grace period for placing non-compliant machinery after that date.

New structure and “high-risk” machinery categories

• The old Annex IV list of high-risk machinery is reorganized into Annex I, Part A and Part B.

• Part A categories will always require Notified Body involvement for conformity assessment. Part B allows more flexibility in the route to conformity, depending on harmonized standards.

Digitalization, AI, and cybersecurity are now clearly in scope

• The Regulation explicitly addresses emerging technologies such as AI, connected machinery, and digital safety components (including safety-related software).

• Risk assessment must now consider both physical hazards and cyber threats that could affect functional safety or create hazardous situations.

Stronger rules on “substantial modification” and incomplete machinery

• The Regulation clarifies when modifications to existing machinery are considered “substantial,” potentially making the modifier a manufacturer with full compliance obligations.

• The long-debated topic of incomplete machinery is tightened up, with clearer requirements on documentation and responsibilities between suppliers and integrators.

Documentation, instructions, and digital formats

• The Regulation allows wider use of digital instructions and digital EU Declarations of Conformity, subject to conditions that ensure users can access the information safely and reliably.

• Technical documentation expectations grow in depth, especially around software, cybersecurity controls, and lifecycle risk analysis.

Market surveillance and penalties

• Member States must put in place stronger sanctions and more proactive market surveillance, with specific obligations phased in before 2027 so authorities are ready on day one.

For manufacturers and integrators, this all translates into earlier involvement of functional safety, cybersecurity, and documentation teams, plus a more structured, traceable risk-management process.

Comparing and contrasting the new rules with the current machinery directive

While the existing machinery directive has been the foundation of EU machine safety for nearly two decades, the 2027 framework changes how compliance is organized and demonstrated.

Form of the law: directive vs regulation

• Today: the machinery directive is implemented through national laws, which can create small differences in interpretation between Member States.

• From 2027: Regulation (EU) 2023/1230 is directly applicable and harmonized, improving consistency across the single market.

Scope and technology coverage

• Today: focus is largely on physical machinery, safety components, and established technologies.

• 2027: explicit coverage for digital safety components, software, connectivity, and AI systems integrated into machinery, plus clearer treatment of partially completed machinery.

Risk assessment expectations

• Today: risk analysis is centered on traditional hazards (mechanical, electrical, ergonomic, etc.).

• 2027: risk assessment must consider cyber risks and their impact on functional safety, and documentation must show how those risks are controlled in design, software, and updates.

Conformity assessment and high-risk products

• Today: Annex IV machinery can often follow Internal Production Control if relevant standards are fully applied, with Notified Body involvement as one option.

• 2027: Annex I Part A machinery is locked into routes that always require a Notified Body, while Part B retains more flexibility, making the high-risk classification more meaningful.

Instructions and documentation format

• Today: paper instructions and declarations are the norm, with limited guidance on digital alternatives.

• 2027: the regulation recognizes digital formats, allowing electronic instructions and declarations where certain accessibility and retention conditions are met, and it raises the bar on the content required for complex, software-driven machinery.

Enforcement and lifecycle oversight

• Today: enforcement tools and penalties are largely defined at Member State level under the directive.

• 2027: the regulation builds in stronger, more harmonized provisions on sanctions, market surveillance, and reporting obligations, aiming for faster intervention when unsafe machinery is found.

In practical terms, the 2027 framework asks you to shift from “CE as a one-time project deliverable” to “CE as an ongoing, lifecycle-wide discipline,” especially for connected, software-driven machinery. Starting gap analyses now, updating your risk-assessment templates, and mapping where Notified Body involvement will be mandatory are all smart moves to ensure you are ready when the law changes.

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