New Regulation (EU) 2023/1230 on Machinery – Key Changes Explained

In June 2023, the long-awaited Regulation (EU) 2023/1230 on machinery was published, replacing the current Machinery Directive 2006/42/EC. This new legislation is essential for manufacturers, importers, distributors, and users across the European Union. It introduces significant changes regarding safety, technical documentation, and modern technologies – including artificial intelligence (AI).

What is Regulation (EU) 2023/1230?

This regulation sets out rules for placing machinery and related products on the EU market. Unlike a directive, a regulation applies directly in all EU Member States and does not require national implementation.

Why is it replacing Directive 2006/42/EC?

• It is directly applicable without transposition
• It reflects digital developments in machinery and software
• It introduces new compliance and documentation requirements

Scope of the new regulation

The regulation covers the design, manufacture, and marketing of machinery, assemblies, interchangeable equipment, and safety components. It also applies to products with AI components or autonomous decision-making capabilities.

Excluded products

• Military and law enforcement machinery
• Exhibition equipment
• Non-commercial research equipment

New obligations for manufacturers and importers

New legal responsibilities have been introduced for manufacturers, importers, and other market players, including:

• Maintaining product compliance throughout its life cycle
• Storing technical documentation digitally
• Providing digital user instructions (printed version on request)

Digital documentation and user manuals

A major change allows user instructions to be provided digitally. A printed version must be available upon user request.

Health and safety requirements

The regulation places a strong emphasis on ensuring user safety, particularly regarding AI risks and cybersecurity.

Risk assessment principles

• Identify potential hazards
• Assess likelihood and consequences
• Implement appropriate protective measures

Roles of supply chain actors

The regulation defines the responsibilities of various actors:

• Manufacturer: designs, manufactures, ensures compliance
• Importer: ensures conformity of products from outside the EU
• Distributor: verifies CE marking and documentation
• Authorized Representative: acts on behalf of the manufacturer

Certification and notified bodies

High-risk machinery must undergo conformity assessment with the involvement of a notified body:

• Quality management system audit
• EU type-examination
• Market surveillance

Changes related to artificial intelligence

• Algorithms must be transparent and controllable
• Learning systems must be safe at every stage

Implementation deadlines and transition period

The regulation was published on 29 June 2023 and will apply from 20 January 2027.

• Time to update documentation
• Personnel training
• Process adjustments

Penalties for non-compliance

• Prohibition from placing products on the market
• Mandatory withdrawal from circulation
• Financial and administrative penalties

Impact on industry and SMEs

For large manufacturers, it’s an opportunity to upgrade compliance systems. For SMEs, it presents an organizational and financial challenge, making support programs essential.

Practical implementation examples

• Company X switched to digital documentation – saved 20% annually
• Manufacturer Y adapted an AI-enabled machine – avoided penalties
• Importer Z implemented a legal compliance audit with a legal advisor

Where to find help and resources?

• EUR-Lex Portal
• National business development agencies
• Technology institutes
• Online training and webinars

FAQ – Frequently Asked Questions

1. Is Regulation 2023/1230 already in force?

No, it will apply starting from 20 January 2027.

2. Is a printed version of the manual required?

No, a digital version is sufficient – unless the user requests a printed one.

3. Does every machine need certification?

No, only high-risk categories must be certified.

4. What about machines with AI features?

They must meet additional safety and transparency requirements.

5. Where can I find technical requirements?

In the annexes to Regulation 2023/1230 available on EUR-Lex.

6. What are the penalties for non-compliance?

Sales bans, product recalls, financial penalties.

Summary and recommendations for businesses

Regulation (EU) 2023/1230 introduces significant changes for the machinery sector. To remain competitive and compliant, businesses should:

• Study the new legal framework
• Update technical documentation
• Train staff on AI and machinery safety
• Consult legal and compliance experts