Preparing for the introduction of the new Machinery Regulations

The European Union is gearing up for a major transformation in machinery regulations with the transition from the Machinery Directive 2006/42/EC to the new Machinery Regulation (Regulation (EU) 2023-1230), effective January 14, 2027. This shift brings the machinery sector into closer alignment with the EU’s New Legislative Framework (NLF) introduced in 2008, which impacts all CE-marked products and specific industry sectors. The update aims to modernize the regulatory framework to address technological advancements and the increasing complexity of machinery and equipment used across diverse industries.

Significant Changes for the Machinery Regulation

Certification Processes: The previous self-certification process in Annex IV is being revised and moved to Annex I. High-risk machinery types, including PTO shafts, vehicle lifts, nail guns, and AI-integrated safety systems, will now require certification by a notified body through type approval (Module B), full quality assurance (Module H), or unit verification (Module G). Less hazardous products listed in Annex I can still undergo self-certification if a harmonized standard is followed.

Digital Instructions and Declarations: New regulations permit digital formats for instructions and declarations of conformity, provided they meet specific criteria:

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

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

• Customizing human-machine interfaces (HMI) to fit operator characteristics
• Ensuring effective communication of machine actions to operators
• Protecting against corruption from connected devices and hacking attempts
• Logging safety-related software changes, updates, decisions, and hacking attempts
• Differentiating between safety-related and non-safety-related software
• Conducting comprehensive safety function risk assessments

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 notified body approval.

Minor Changes for the Machinery Regulation

Alignment with the New Legislative Framework: These changes, long overdue, incorporate clearer rules for traceability and product recalls, a new format for the EU declaration of conformity, 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, with the representative no longer handling tasks like risk assessment and technical documentation.

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

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

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 Stakeholders

Most machinery manufacturers within the EU will notice only minor differences. However, importers and distributors will face new obligations, many 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 is 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 addressing 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-integrated 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