From the Machinery Directive to the Machinery Regulation

The EU's response to technological evolution. TÜV Italia takes a look at the new regulations contained in the regulation that updates a Directive that has been in force for the past 15 years.

The profound changes in the world of design and production of machines and machinery, which are increasingly integrated with digitalised systems, elements of robotics, artificial intelligence and automation, have called for an update of the Machinery Directive, starting from its name, which has now become a Regulation, and is aimed at further improving the safety of machines within the European Union.

This prompted the amendment of the Machinery Directive (EC) 2006/42, responding to the need to keep pace with rapid technological developments and address emerging risks in the sector, such as the integration of artificial intelligence and robotics.

These issues are behind the change and the promulgation of the new Machinery Regulation (EU) 2023/1230, which ensures that machinery marketed in the EU complies with more stringent safety requirements, providing greater protection for users and the environment.

The first and most obvious change is in the nomenclature: regulation instead of directive. This ensures a more harmonised and standardised approach across the EU. In fact, unlike directives, which also need a national transposition decree, regulations come into force immediately on the date set by the regulation itself and apply automatically and uniformly throughout the EU. A second important change regards the involvement of third-party organisations, the assessment of which becomes mandatory for various types of machinery.

The new Machinery Regulation (EU) 2023/1230 published on 29/06/2023 will officially enter into force in the EU on 19/07/2023 and will be applicable from 14/01/2027, the latter date marking the definitive repeal of the Machinery Directive (EC) 2006/42.

The other key changes under the new Regulation are:

• Integration of the provisions on artificial intelligence: the Regulation applies to systems using AI technologies for aspects concerning possible influences on machine safety;
• Enhanced cyber security measures: the new Machinery Regulation requires control circuits, which perform safety functions, to be designed to prevent malicious attacks that might cause dangerous machine behaviour (cyber security);
• Automated and remote-controlled machines: the Regulation defines guidelines to ensure the safe use and operation of automated and remote-controlled machines;
• Digitised instructions and declarations: the instructions for use, in the case of machinery, and the assembly instructions, in the case of quasi machines. Similarly, declarations of conformity/incorporation can be provided by the manufacturer in digital format.
• Mandatory assessment by a notified body: Six product categories require mandatory conformity assessment by third-party bodies. These include machines and safety components with machine learning behaviour;
• Common specifications: when suitable harmonised standards are not available, common specifications provide a fallback option, ensuring clarity and consistency;
• Simplified safeguard procedures: safeguard procedures have been simplified and aligned with other relevant legislation to enable efficient and effective safety measures.