Introducting the Machinery Regulation: Understanding the changes from the Machinery Directive

The European Union is on the brink of a transformative shift in machinery regulation, transitioning from the existing Machinery Directive 2006/42/EC to the new Machinery Regulation (Regulation (EU) 2023-1230), set to be enforced starting January 14, 2027. This change aligns the machinery sector more closely with the EU’s New Legislative Framework (NLF) introduced in 2008, affecting all CE-marked products and specific sectors. The revision is designed to modernize regulations in response to technological advancements and the growing complexity of machinery and equipment across industries.

Key Changes for the Machinery Regulation

Certification Processes: The previous self-certification system outlined in Annex IV is being revised and relocated to Annex I. High-risk machinery types, such as PTO shafts, vehicle lifts, nail guns, and AI-based safety systems, will now require certification by a notified body via type approval (Module B), full quality assurance (Module H), or unit verification (Module G). However, less hazardous products listed in Annex I can still be self-certified if a harmonized standard is applied.

Digital Instructions and Declarations: New provisions allow digital formats for instructions and declarations of conformity, provided they meet the following conditions:

• Accessible through a link on the machinery
• Printable and downloadable to an electronic device, even if instructions are embedded
• Available online for the machinery’s lifespan (or ten years for declarations)
• Obtainable in paper form from the manufacturer

Functional Safety and Cybersecurity Enhancements: The regulation introduces updates for functional safety and new cybersecurity requirements, particularly for autonomous and self-evolving machinery. These requirements include:

• Adapting human-machine interfaces (HMI) to operator characteristics
• Ensuring effective communication of machine actions to operators
• Protecting against corruption from connected devices and hacking
• Recording safety-related software changes, updates, decisions, and hacking attempts
• Distinguishing between safety-related and non-safety-related software
• Conducting formal safety function risk analyses

Safety-related software is classified as a safety component if marketed separately. If the software is self-evolving, it falls under Annex IA and requires approval from a notified body.

Minor Changes for the Machinery Regulation

Alignment with the New Legislative Framework: These adjustments, long overdue, incorporate clearer rules for traceability and product recalls, a new EU declaration of conformity format, importer and distributor requirements, and clarification that own-brand labelers and machinery modifiers are considered manufacturers. The responsibilities that manufacturers can delegate to an authorized representative are now more restricted, and the representative cannot handle tasks like risk assessment and technical documentation.

Machinery Categories Clarified: The regulation introduces clearer categories to eliminate previous confusion:

• Machinery: Encompasses complete machinery ready for use.
• Machinery Related Products: Includes interchangeable equipment, safety components, lifting accessories, and removable mechanical transmission devices.
• Partly Completed Machinery: Covers sub-assemblies intended for incorporation into finished machinery by another manufacturer, requiring a declaration of incorporation and a final assessment before market placement.

These categories are collectively referred to as ‘products within the scope of this regulation.’

Directive to Regulation Transition: Unlike directives, which require national transposition, regulations are directly applicable across all EU member states, ensuring a uniform set of rules.

Substantial Modification: The threshold for modifications that necessitate re-certification to CE standards was previously defined in guidance and is now included in the regulation.

Instructions and Translation Requirements: The requirement for ‘Original Instructions’ or ‘translation of the original instructions’ in manuals has been removed, eliminating the need to specify whether the content was checked by the manufacturer or written by a translator.

Existing certificates remain valid until expiration, even beyond January 2027.

Implications for Industry Stakeholders

Most EU machinery manufacturers will experience minimal changes. However, importers and distributors face new obligations, many of which were introduced in 2020 with the Market Surveillance and Safety of Products regulation. Manufacturers of networked and autonomous machinery, in particular, will need to address more substantial new obligations. It’s crucial for manufacturers to review and adjust their compliance strategies to align with the new regulation.

The Machinery Regulation (Regulation 2023-1230) represents a proactive approach to machinery safety and regulation, poised to make a substantial impact on the industry. By tackling modern technological challenges, the EU aims to enhance safety, facilitate market access, and foster innovation within the machinery sector.

Key Points:

• PTO shafts, vehicle lifts, nail guns, and AI-based safety systems require notified body certification for CE marking.
• Digital instructions and declarations are permissible under certain conditions.
• Updated functional safety requirements
• New AI system requirements
• Expanded rules for importers and distributors
• Limited roles for authorized representatives