Application:
The Machinery Regulation enters into force on 19th July 2023 and will be applicable from 20 January 2027, i.e. 42 months after the entry into force, Art. 54 of the Machinery Regulation. All parties concerned – in particular manufacturers, importers, authorized representatives, distributors and operators – have therefore time to prepare for the new rules. However, the new rules must be fully complied with by 20 January 2027. This means that companies should start considering the new requirements well in advance of the deadline, as it takes time to prepare the documentation and certifications required by the new regulations.
The Machinery Regulation is structured according to the New Legislative Framework (“NLF”). As is well known from European product compliance, all economic operators now have allocated responsibilities. One of the practically "most visible" effects: machinery importers must now be labelled with their name and address.
Main changes:
The Machinery Regulation introduces relevant changes, among which:
Legal status: as a Regulation, the Machinery Regulation provides more harmonisation as well as direct application throughout the EU. Manufacturers will not need to wait for each country’s transposition in national law, which may introduce stronger national requirements.
Paperless: Manufacturers can now digitize their instructions for use. They remain, however, obliged to ensure that distributors can provide the user of the machinery with a printed version of the instructions free of charge when purchasing the machinery (cf. recital 40). If the manufacturer opts for digital instructions, he must (i) indicate on the machinery how the instructions can be accessed and (ii) provide the instructions in a "printable format" (PDF), Art. 10 para. 7 of the Machinery Regulation.
Common specifications: the Machinery Regulation gives rules for the development of common specifications, in case there are issues to develop a harmonised standard for a specific machine.
Substantial modification: The Machinery Regulation codifies the term "substantial modification" in Art. 3 No. 16. Anyone who makes a "substantial modification" to a machinery is considered a manufacturer and must therefore fulfill all obligations associated with this role, in particular needs to carry out a new conformity assessment. This obligation is in principle limited to the modified part of the machinery. The situation is, however, different if the modification concerns the machinery as a whole, see Art. 18 and Recital 26 of the Machinery Regulation. In future, companies will see themselves more quickly confronted with a substantial modification because the requirements changed: contrary to the Interpretation paper of the Federal Ministry of Labour and Social Affairs from 2015, a substantial modification will also exist if the machinery can be returned to a safe condition by a "simple protective device".
Conformity Assessment: the general principle for the conformity assessment of the machinery is self-compliance. Machinery indicated in a list included in the Regulation must undergo validation through notified bodies (external accredited centres). Under the Machinery Directive there was the possibility to apply for self-compliance when an existing harmonised standard covers all its relevant hazards; under the Machinery Regulation this possibility was revoked for some specific machinery or components. In particular, power take-off (PTO) drive shafts and their guards or simply guards to PTOs, when they are placed alone on the market, will need to be validated by a notified body.
Machine learning: The bottom line is that the machines in Annex IV of the Machinery Directive are now – with some additions – listed in Annex I of the Machinery Regulation. If the machines are listed in Part A of Annex I of the Machinery Regulation (e.g. machineries whose safety functions are provided by the system with "self-evolving behaviour"), one of the following, more comprehensive conformity assessment procedures, must be applied: either (i) EU type-examination followed by conformity to type based on internal production control, (ii) unit verification or (iii) full quality assurance, Art. 25 para. 2 of the Machinery Regulation. For machinery listed in Annex I Part B of the Machinery Regulation, the same conformity assessment obligations apply if the manufacturer has not designed and built it entirely in accordance with the relevant harmonized standards or common specifications, Art. 25 para. 3 of the Machinery Regulation. This is already established in Art.12 para. 4 of the Machinery Regulation.
Partly completed machinery; The new Machinery Regulation explicitly covers machinery, related products and partly completed machinery, Art. 2 of the Machinery Regulation. The European legislator is attempting to eliminate previous ambiguities regarding the scope of the preceding Machinery Directive with other harmonized legal acts, in particular with the Low Voltage Directive and the Radio Equipment Directive. For example, Art. 2 para. 2 lit. p of the Machinery Regulation clarifies that the scope of the Machinery Regulation does not apply to electrical and electronic products specifically defined in the Regulation, insofar as they are subject to the Low Voltage Directive or the Radio Equipment Directive.
After-market obligations for manufacturers: In line with the implementation of the NLF, the new Machinery Regulation now also explicitly provides for after-market obligations for manufacturers. Art. 10 para. 9 of the Machinery Regulation explicitly states that manufacturers must "immediately take the corrective actions necessary" to ensure their conformity with the Regulation. This includes notifying the competent national authorities and withdrawing or recalling the products concerned.
Technical Requirements:
The technical requirements are gathered in a specific annex to the Machinery Regulation. Compared to the Machinery Directive, the numbering remains unchanged. Here below is an overview of the main changes.
Protection against corruption/Safety and reliability of control systems: The Machinery Regulation extends the protection against external influences, when they would result in a dangerous behaviour of the machine. This impacts both the protection of the machinery and the behaviour of control systems (cybersecurity). Another digitalization component of the Machinery Regulation is its cybersecurity requirements. Manufacturers must take appropriate measures (now explicitly required by law) to ensure the security of their machinery against potential cyber threats and protection against interference. This includes the implementation of security measures to prevent accidental or intentional corruption, manipulation or theft of data, cf. Annex III Sec. 1.1.9, Sec. 1.2.1 of the Machinery Regulation.
Therefore, the manufacturer is required to identify key data or key software, the versions of the software installed, the proof of interventions. The upcoming publication of the Cyber-Resilience Act should cover this in detail. On remote controls, a communication or a connection failure must not lead to a dangerous situation either.
Manufacturers of mobile machinery will need to:
Provide a filtered cab for machines with ride-on driver, when the main use of the machine is the application of hazardous substances. This is typically the case for self-propelled sprayers.
Provide an audible and visual warning when the seat belt is not fastened on machines presenting a risk of overturning. Additionally, where there is a significant risk of roll or tip over and its restraint system is not used it shall not be possible for the machinery to move.
Take into account the possibility of contact with overhead power lines. Manufacturers will need to do this firstly with measures to avoid the contact or the creation of an electric arc, and secondly through solutions to prevent electrical hazards in case the contact occurs.
For autonomous mobile machinery, a set of new requirements was introduced:
The possibility to have a supervisor and a related supervisory function. This role intends to monitor the actions of the robot when it is in autonomous mode. The robot must send information and alerts to the supervisor who has the possibility to stop, re-start the machine in autonomous mode, or to bring it to a safe position.
The robot must travel safely in a defined working area (also for the automatic charging of the batteries), using either a physical borders or obstacle detection.
Finally, for machines fitted with fully or partially self-evolving logic or behaviour, the risk assessment will need to take into account the behaviour of the machine after it is placed on the market. This measure targets in particular the movement space and the tasks it will perform. The manufacturer will need to ensure good connection between the operator and the machinery, when it comes to communication and to forces used to carry out a task. Finally, the data related to a software of a safety function taking decision will have to be stored each time a decision is taken.
If you would like more advice on the new machinery regulations or you require assistance with your compliance projects please feel free to contact us;
CE Marking Authority,
30A Main Street, Hatton,
Peterhead, Aberdeenshire
AB42 0SB UK
Tel +44 1779 841842 Mobile +447910 523528
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