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From the directive to the machinery regulation: implications, challenges and impacts of digitalisation, ai and safety in European industry

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Resumo(s)

The current industrial paradigm, commonly referred to as Industry 4.0, is characterized by the interconnection of cyber-physical systems (CPS), artificial intelligence and connectivity on the shop floor. This technological evolution brings benefits in terms of efficiency and flexibility, but at the same time introduces security challenges that existing regulatory frameworks do not anticipate. The recent publication of Regulation from Europea Union (EU) 2023/1230, which replaces the current Directive 2006/42/EC, represents the legislative response to these new challenges by imposing new requirements in the areas of cybersecurity, safety-critical software and machine learning systems. The main aim of this paper is to carry out a comparative analysis between Directive 2006/42/EC and the new EU Regulation 2023/1230 given the recent shifts in the industrial paradigm, particularly due to the emergence of Industry 4.0 and 5.0, which are manifesting themselves in the areas of industrial automation, cyber-physical systems, digitalization and artificial intelligence, technical challenges have arisen that are reflected in the gaps in the current Machinery Directive (2006/427/EC). This article aims to analyze emerging technological challenges, with a particular focus on the risks associated with collaborative robotics, cybersecurity and machine learning systems, by systematizing the necessary knowledge and highlighting the gaps in the current directive, thereby demonstrating how the new regulation aims to address these new security challenges.

Descrição

Palavras-chave

Machinery directive Machinery regulation Industry 4.0 Industry 5.0 Industrial automation Collaborative robotics Cybersecurity

Contexto Educativo

Citação

Santos, A.A., Pinho, G., Pereira, F., Silva, A.F., Silva, P.J., Pinto, M., & Felgueiras, C. (2026). From the directive to the machinery regulation: implications, challenges and impacts of digitalisation, ai and safety in European industry. IJOMAM, 1(25), 7-15. dx.doi.org/10.17683/ijomam/issue25/v1.1

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Cefin Publishing House

Licença CC

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