If you manufacture, import, or integrate machinery for the European market, one date should already be on your radar: 20th January 2027. From that point on, the current Machinery Directive will be replaced by Regulation (EU) 2023/1230, introducing a new legal framework for CE marking of machinery in the EU.
Although the core goal remains the same—placing safe machinery on the market—the way compliance is achieved and demonstrated will change in meaningful ways.
Why It Matters
The most fundamental shift is legal in nature. The existing Machinery Directive 2006/42/EC relies on national implementation, which can lead to differences in interpretation between countries.
The new Machinery Regulation, by contrast, applies directly across all EU and EFTA states. This means a single, harmonised set of rules taking effect everywhere at the same time, reducing ambiguity but also leaving less room for local flexibility.
There is no transition buffer once the regulation applies.
- Machinery placed on the market before 20th January 2027 must comply with the current directive.
- Machinery placed on the market from that date onward must comply with the new regulation.
Any equipment that does not meet the new requirements after the deadline cannot legally be placed on the EU market.
High-Risk Machinery Gets a New Structure
The familiar Annex IV list of high-risk machinery is reworked into Annex I, Part A and Part B.
- Annex I Part A machinery will always require assessment by a Notified Body.
- Annex I Part B machinery may still follow different conformity routes, depending on the use of harmonised standards.
This change makes the high-risk classification more decisive and reduces uncertainty around when third-party involvement is mandatory.
Technology
One of the biggest drivers behind the new regulation is the rise of software-driven and connected machinery. The updated framework explicitly covers:
- Safety-related software
- Connected and networked machinery
- Artificial intelligence used in machine functions
- Cybersecurity risks that could impact safety
Risk assessments must now go beyond physical hazards and consider how cyber threats or software failures could lead to unsafe conditions.
Clearer Rules on Modifications and Incomplete Machinery
The regulation provides long-awaited clarification on when a modification becomes “substantial.” In such cases, the party making the change may take on full manufacturer responsibilities for compliance and CE marking.
Requirements for partly completed machinery are also tightened, with clearer expectations around documentation, instructions, and responsibilities between suppliers and system integrators.
Digital Instructions and Expanded Documentation
The new rules allow for wider use of digital instructions and electronic EU Declarations of Conformity, as long as users can access the information reliably throughout the machinery’s lifecycle.
At the same time, technical documentation requirements are expanded; particularly for software design, cybersecurity controls, and lifecycle risk management.
Stronger Market Surveillance and Enforcement
The regulation introduces more robust enforcement mechanisms, including stronger sanctions and more proactive market surveillance. Member States are required to have these systems in place ahead of 2027, with enforcement to begin immediately thereafter.
What Manufacturers Should Do Now
Starting early is key. Conducting gap analyses, updating risk assessment methodologies, and identifying where Notified Body involvement will be required can help avoid last-minute disruptions and ensure a smoother transition when the regulation takes effect.
Get in touch with us!
Need more help with machinery compliance? Earlsmere are established UK & EU based authorised representatives with over 25 years of experience, trusted by leading Notified Bodies in UK & Europe. Our dedicated team have extensive knowledge of machinery safety standards & outdoor machinery sound power assessments.
UK: sales@earlsmere.co.uk / +44 1226 750 111
