On 29 June 2023, Regulation (EU) 2023\/1230 on machinery was published in the Official Journal of the European Union. It will replace the current Machinery Directive 2006\/42\/EC from 20 January 2027. For Chinese manufacturers exporting machinery to Europe, this regulatory change introduces new and more stringent requirements that need to be understood well in advance. <\/p>\n\n
Why the legislation is changing<\/strong><\/p>\n\n The 2006 Machinery Directive was designed in a very different technological context. The growing prevalence of connected machines, AI systems integrated into industrial machinery, and advanced automation technologies has made a thorough update of the European regulatory framework necessary. <\/p>\n\n Key changes under Regulation 2023\/1230<\/strong><\/p>\n\n \u2014 Legal form: the shift from a Directive (which required transposition by each member state) to a Regulation (directly applicable in all EU countries without national transposition) ensures greater uniformity in application.<\/strong> <\/p>\n\n \u2014 Connected machines and AI: the new Regulation introduces specific requirements for machines incorporating artificial intelligence systems or connected to networks, in line with the new EU AI Act.<\/strong><\/p>\n\n \u2014 Conformity assessment: for certain categories of high-risk machinery, the Regulation introduces a mandatory requirement to involve a Notified Body in the conformity assessment procedure, even where internal procedures were previously sufficient.<\/strong><\/p>\n\n \u2014 Technical file: the requirements for the technical file have been expanded and made more detailed, with new provisions for documentation related to AI-related risks.<\/strong><\/p>\n\n \u2014 Digital instructions: the Regulation allows, for the first time, the provision of instructions for use in digital format, provided that printing remains possible.<\/strong><\/p>\n\n What Chinese manufacturers need to do<\/strong><\/p>\n\n Chinese manufacturers exporting machinery to Europe have until 20 January 2027 to comply with the new Regulation. However, it is strongly advisable to begin the compliance analysis at least 12\u201318 months in advance, given the time required to revise the technical file, update manuals, and potentially involve a Notified Body. <\/p>\n\n Rxconsult, through Ing. Marco Ussei, offers a free preliminary analysis to assess companies’ position with respect to the new Regulation and plan the necessary adaptation activities.<\/p>\n","protected":false},"excerpt":{"rendered":" On 29 June 2023, Regulation (EU) 2023\/1230 on machinery was published in the Official Journal of the European Union. It will replace the current Machinery Directive 2006\/42\/EC from 20 January 2027. For Chinese manufacturers exporting machinery to Europe, this regulatory change introduces new and more stringent requirements that need to be understood well in advance. 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