Machinery Directive becomes Machinery Regulation

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With publication in the Official Journal of the European Union in 2023, it is now binding that the new EU Machinery Regulation will replace the Machinery Directive as the most important legal provision for machinery safety. Machine safety specialist Pilz explains what this will mean to companies that design, build and sell machinery.

New approaches and issues, such as digitisation, required the ongoing development of the Machinery Directive. After a transition period, the new Machinery Regulation will apply to all companies in the European Economic Area that design, build and sell machinery. Machines that are imported into the area of European jurisdiction also have to meet the requirements.

The EU Machinery Regulation came into force in all EU member states 20 days after it was published in the Official Journal. As a machine manufacturer you then have 42 months to comply with the new requirements for plant and machinery. Thus, the Machinery Regulation (MR) will become mandatory in 2027.

Key changes

The Machinery Regulation gives machine manufacturers more precise specifications for how to handle substantial modifications on a machine, as well as machines subject to inspection. What’s more, it also takes into account the growing importance of digitisation and Industrial Security: It describes requirements for the cybersecurity of products as well as digital instructions. The MR covers machinery, as before, and now also ‘related products’.

  • 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 are 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 the 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 user 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.
  • The emergence of new digital technologies such as artificial intelligence, the Internet of Things and robotics present new challenges for product safety. The regulation covers the safety risks arising from new digital technologies.
  • 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. Manufacturers will need to 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 may be provided in digital form, and partly completed machinery may be delivered with digital assembly instructions and with a digital declaration of incorporation.

Harmonised standards

It is still unclear how the process will run with the existing harmonised standards under the Machinery Directive. As it currently stands, these will need to be relisted. With over 750 directly listed standards alone, that means a significant effort over several years. With a defined transition period of 42 months, the standards committees now have a lot of work ahead of them. It will be interesting to see whether the relevant standards will be available as harmonised standards by the time the EU Machinery Regulation comes into force 2027.

As a machinery safety expert, Pilz is actively involved in the creation of new legislation and is always informed on the latest developments. To keep up to speed on the Machinery Regulation and to download a whitepaper on the topic visit the company’s website.

pilz.co.uk/mr  

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