EU Machinery Regulation from 20 January 2027

The official title of the Machinery Regulation is:
Regulation (EU) 2023/1230 of the European Parliament and of the Council on machinery.

If you compare today’s technical requirements of automation and engineering with those of 2009, it is clear that the revision of the directive was inevitable.
Digitisation and networking, as well as the new related issues of Industrial Security and Artificial Intelligence (AI), are in the process of significantly changing factory halls and the plant and machinery within them.
To take account of these changes, the provisions have been brought in line with technical developments.

The new European Machinery Regulation (EU) 2023/1230 contains comprehensive rules on machinery health and safety, including new technologies such as Artificial Intelligence. Key points are safety requirements, new conformity assessment procedures and stricter market surveillance.

• Machines subject to inspection
  The list of machines subject to inspection, which was previously in Annex IV of the Machinery Directive 2006/42/EC, has “moved” to Annex I. In Section A it contains a list of high risk machines, for which mandatory inspection and certification through a third party is required. In future, six machine categories will be subject to inspection; application of a harmonised standard does not remove the inspection obligation. This is due to the current developments in Artificial Intelligence. For the six listed product groups, machine manufacturers can no longer self-declare compliance in conjunction with a harmonised standard, as previously. Instead, a named accreditation body must be involved.

• Substantial modification
  The regulation has been extended to include a definition of a substantial modification of machinery and the legal consequences of such a modification. A conformity assessment procedure is required for Machinery Safety if a machine undergoes major modifications or when changes are made that affect the machine’s compliance with the statutory provisions for CE marking. If a substantial modification has taken place, the operator becomes the manufacturer – with all the obligations that entails.
   
• Safety components
  The definition of safety components now includes not only physical, digital and/or mixed-type components, but also software.
   
• Digital technologies
  The emergence of new digital technologies such as Artificial Intelligence, the Internet of Things and robotics present new challenges for product safety.
   
• Industrial Security
  In a new section entitled “Protection against corruption”, the Machinery Regulation now also establishes requirements for the cybersecurity of machinery. Cybersecurity threats must not be allowed to compromise the machine’s safety functions. So measures to counteract these threats are no longer open to the interpretation of the person placing the machine on the market, but are a mandatory component. Manufacturers must review their existing safety concepts in this regard!
   
• Digital instructions
  Manufacturers shall be allowed to supply instructions in digital form. Should the customer request it, the manufacturer must supply the instructions in paper format. The EU Declaration of Conformity can also be provided in digital form. Partly completed machinery can be delivered with digital assembly instructions as well as with a digital Declaration of Incorporation.

The Machinery Directive (2006/42/EC) is the current and final version of the Machinery Directive. Application has been mandatory in the European Union since 2009 and continues to apply until the Machinery Regulation comes into force.

The Machinery Regulation aspires to maintain the high level of safety that was achieved with the implementation of the specifications from the Machinery Directive and to bring it up to date with state-of-the-art technology. The aim is to design safe interaction between human and machine, and to guarantee the standardisation of fundamental and mandatory European Machinery Safety requirements.

The new regulation continues to cover machinery and related products that are to be operated within the European Union, but safety components now also include software.