38 n SAFETY November/December 2024 www.drivesncontrols.com What does the Machinery Regulation mean for you? The Machinery Directive (2006/42/EC) is the current – and nal – version of the Machinery Directive. Its use has been mandatory in the EU since 2009. It is aimed primarily at manufacturers and requires safety to be guaranteed when human and machine interact. If you compare the automation and engineering of today with the technical requirements of 15 years ago, it is clear that the revision of the Directive was more than sensible. Digitisation and networking, as well as the related issues of industrial security and AI (arti cial intelligence), are signi cantly changing factory halls and the plant and machinery within them. The new Machinery Regulation, which came into force in all EU member states on 19 July 2023, aspires to maintain the high level of safety that was achieved with the Machinery Directive. This means that you must meet all of the speci cations of the new Regulation within the transitional period which lasts until January 2027. Companies face an enormous challenge implementing the speci cations of the new Regulation in terms of risk analysis, instructions for use and technical documentation, as well as conformity assessment and declaration of conformity with subsequent CE marking. The birth of modern machinery safety dates back less than 40 years. The change was brought about in 1989 with the arrival of the Machinery Directive. Since then, machinery safety has been mandatory in Europe. Its provisions have consistently been brought in line with technical developments. The aim has always been to design safe interaction between human and machine, and to promote the standardisation of fundamental and mandatory machine safety requirements. The publication of the EU Machinery Regulation 2023/1230 on 29 June 2023 has brought the speci cations up to the current state-of-the-art. The Regulation becomes legally binding in all EU states on 20 January 2027. What are the changes? The new regulation continues to cover machinery and related products, but safety components now also include software. It provides greater clarity as to when there is a substantial modi cation to existing plant and machinery, and therefore a new CE conformity assessment needs to be conducted. It also takes into account the growing importance of industrial security and digitisation. Security is a mandatory element for the safety of machinery, and no longer open to the interpretation of those placing the machine on the market. Manufacturers will need to draw up appropriate industrial security concepts. In this respect, security is one of the main themes of the new Machinery Regulation. Manufacturers of networked machinery should prepare well in this regard. They will also face demands from other areas of legislation – for example, the Cyber Resilience Act and the Radio Equipment Directive. The most important changes in the Regulation cover: nMachines subject to inspection The list of machines subject to inspection, which was previously in Annex IV of the Machinery Directive, has moved to Annex I. In Section A, it contains a list of high-risk machines, for which mandatory inspection and certi cation 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 obligation for inspection. This is due to current developments in AI. For the six listed product groups, machine manufacturers can no longer self-declare compliance in conjunction with a harmonised standard, as before. Instead, a named accreditation body must be involved. nSubstantial modi cations The regulation has been extended to include a de nition of a substantial modi cation of machinery and the legal consequences of such a modi cation. A conformity assessment procedure is required for machinery safety if a machine undergoes major modi cations or when changes are made that aect the machine’s compliance with the statutory provisions for CE marking. If a substantial modi cation has taken place, the operator becomes the manufacturer – with all of the obligations that entails. nSafety components The de nition of safety components now includes not only physical, digital and/or mixed-type components, but also software. n New digital technologies The emergence of new digital technologies such as AI, the IoT and robotics, present new challenges for product safety. The regulation covers the risks arising from new digital technologies. nCybersecurity In a new section entitled Protection against corruption, the Machinery Regulation establishes requirements for the cybersecurity of machinery. Cybersecurity threats must not be allowed to compromise the machine’s safety functions. Manufacturers must review their existing safety concepts in this regard. nDigital instructions Manufacturers will be allowed to supply instructions in digital form. Should the customer request it, the manufacturer must supply the instructions in paper Last year, the EU published its new Machinery Regulation which will supersede the Machinery Directive that was issued in 2006. Machine manufacturers have until January 2027 to comply with the new safety requirements on plant and machinery. Matthias Wimmer, application standards specialist at Piz Automation Technology, explains the implications of the new Regulation and how its diers from the Directive.
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