Machinery Directive is changing to the Machinery Regulation 2023/1230: What you need to know

The European Union is poised for a significant regulatory shift in the machinery sector with the transition from the Machinery Directive 2006/42/EC to the Machinery Regulation (Regulation (EU) 2023-1230), which enters into force on January 14th, 2027. This transformation aligns the machinery sector more closely with the New Legislative Framework (NLF) introduced by the EU in 2008 for all CE marked and other specific product sectors. The revision aims to modernize the regulatory landscape, addressing advancements in technology and the increasing complexity of machinery and equipment used across various industries.

Key Changes for the Machinery Regulation

1. Certification Processes: The self-certification process previously provided in Annex IV is being modified and moved to Annex I. The highest-risk machinery types listed such as PTO shafts, vehicle lifts, nail guns and safety systems using AI will now need notified body certification by type approval (Module B), Full quality assurance , (Module H), or unit verification (Module G.) The remaining less hazardous products listed in Annex I can still be self-certified if a harmonised standard is followed.
2. Digital instructions and declaration of conformity will be allowed as long as they are:
   • accessible with a link on the machinery,
   • printable and downloadable to an electronic device (even if the instructions are embedded on the machinery.)
   • accessible online for the life of the machinery (or 10 years for declarations)
   • available from the manufacturer on paper.

3. Enhancements to Functional Safety and Cybersecurity of control systems: The new regulation has upated for functional safety. There are also new requirements for cybersecurity and autonomous and self-evolving machinery. These include:
   • adapting the HMI to the characteristics of operators
   • communicating the machine’s actions effectively to the operator
   • protecting against corruption by connected devices and hacking
   • recording safety-related software changes, software updates, safety related decisions and hacking attempts.
   • identifying safety-related and non-safety-related software
   • completing a formal safety function risk analysis
4. Safety-related software becomes a safety component if it is placed on the market separately. If it is self-evolving, it is in Annex IA and requires notified body approval.

Minor Changes for the Machinery Regulation

1. Alignment with the New Legislative Framework. These requirements were incorporated into most other product legislation about ten years ago and revision is long overdue. They include:
   • Clearer rules on traceability and product recall
   • A new EU declaration of conformity with a specific format
   • New requirements for importers and distributors
   • Clarification that own-brand-labellers and modifiers of machinery are considered to be the manufacturer
   • The responsibilities the manufacturer can delegate to an authorised representative are now more limited. The AR cannot now be responsible for such things as the risk assessment and technical documentation
   • New requirements for authorities, notified bodies and other areas of the framework.
2. Clarification of Machinery Categories: The regulation introduces clearer categories of machinery to eliminate confusion and ambiguity. The categories are:
   • Machinery: This remains the primary category, encompassing complete machinery ready for installation and use.
   • Machinery Related Products: This includes interchangeable equipment, safety components, lifting accessories; chains, ropes and webbing and removable mechanical transmission devices. The directive was confusing in as it called this category Machinery too.
   • Partly Completed Machinery: This category covers machinery sub-assemblies intended to be incorporated by another manufacturer into finished ‘machinery.’ It is supplied with a declaration of incorporation that requires the incorporator to do a final assessment before placing the machinery on the market.

Together these categories are referred to as ‘products within the scope of this regulation’

3. Shift from a directive to a regulation: Unlike directives, which require transposition into national laws, regulations are directly applicable across all member states, making a smoother path to a uniform set of rules.
4. Substantial modification, the threshold of modification that requires a modified machine to be CE marked again was already defined in guidance. Now this is included in the regulation.
5. ‘Original Instructions’ or ‘translation of the original instructions’ was required in the manual to tell the user whether it has been checked by the manufacturer or written by a translator. It has been removed from the regulation.
6. Existing certificates remain valid until they expire, even if this is after January 2027.

Implications for Stakeholders

Most manufacturers, of machinery in the EU will only notice minor differences. Importers, and distributors have new obligations although most of these arrived in 2020 with the Market Surveillance and Safety of Products regulation. Some manufacturers, particularly of networked and autonomous machinery will have more significant new obligations. Manufacturers must assess their current compliance strategies and make necessary adjustments to comply with the new regulation.

The Machinery Regulation (Regulation 2023-1230) represents a forward-looking approach to machinery safety and regulation, poised to significantly impact the industry. By addressing modern technological challenges with this new legislation, the EU aims to enhance safety, facilitate market access, and foster innovation in the machinery sector.

Headlines:

• PTO shafts, vehicle lifts, nail guns and safety systems using machine learning can no longer be CE marked without notified body certification.
• Information for use can supplied digitally subject to some conditions.
• Functional safety requirements have been updated,
• AI systems have new requirements
• New rules for importers and distributors as well as expanded requirements for manufacturers
• Authorised Representatives have a more limited role.