{"id":28846,"date":"2023-02-10T14:27:05","date_gmt":"2023-02-10T13:27:05","guid":{"rendered":"https:\/\/www.gt-engineering.it\/approfondimenti\/%tipologia_approfondimento%\/machinery-product-regulation\/nuovo-regolamento-macchine-principali-modifiche-2\/"},"modified":"2026-02-18T09:54:15","modified_gmt":"2026-02-18T08:54:15","slug":"nuovo-regolamento-macchine-principali-modifiche-2","status":"publish","type":"approfondimento","link":"https:\/\/www.gt-engineering.it\/en\/insights\/machinery-directive\/machinery-product-regulation\/nuovo-regolamento-macchine-principali-modifiche-2\/","title":{"rendered":"The main changes"},"content":{"rendered":"\n\n \n \n \n
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According to the EU, the key objective of the new Regulation is to clarify and future-proof legislation in this area, bringing specifications up to the current state of the art. Whilst some requirements remain the same, the new Regulation introduces some key changes to machinery legislation in the EU which includes, but is not limited to, the following:<\/p>\n

    \n
  • Alignment to New Legislative Framework (NLF) \u2013 the EU has aligned the Machinery Regulation to NLF legislation, therefore introducing obligations on importers and distributors that did not previously apply to machinery products.<\/li>\n
  • Move towards paperless compliance \u2013 manufacturers can provide digital documentation rather than paper format, although paper formats must be provided if requested.<\/li>\n
  • Common specifications \u2013 the EU can create common specifications, in the absence of a harmonised standard, to provide presumption of conformity to the essential health and safety requirements in the Regulation.<\/li>\n
  • Conformity assessment \u2013 the EU has introduced new requirements, with a list of products that now require mandatory third-party conformity assessment due to their deemed risk level.<\/li>\n
  • Changes to essential health and safety requirements (EHSRs) \u2013 there are a number of changes to the EHSRs, such as new requirements related to software and machines with self-evolving behaviours.<\/li>\n<\/ul>\n

    Hereafter we analyse a few of those changes<\/p>\n<\/div> <\/div>\n \n \n

    <\/div>\n \n\n <\/div>\n <\/section>\n\n \n\n\n\n\n \n \n \n
    \n\n \n
    \n \n
    \n \n \n

    \n New definition of “partly completed machinery” <\/h2>\n <\/div>\n <\/div>\n \n \n \r\n\r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n <\/picture>\r\n\r\n \r\n\r\n \r\n \r\n <\/div>\n \n
    \n \n
    \n

    Hereafter the new language and the today\u2019s one<\/p>\n

    [New M.P.R.] \u2013 Art. 3. Definitions<\/strong><\/p>\n

    (10) \u2018partly completed machinery\u2019 means an\u00a0assembly which is machinery but for the fact that it cannot in itself function so as to perform a specific application and which is only intended to be incorporated into or assembled with machinery or other partly completed machinery or equipment, thereby forming a machinery product;<\/p>\n

    [2006\/42\/EU] \u2013 Art. 2. Definitions<\/strong><\/p>\n

    (g) \u2018partly completed machinery\u2019 means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies;<\/p>\n

    A machine that carries out a very specific application, inserted in a production line and which needs signals from the rest of the line in order to function, is in effect a partly completed machine \u201cfor the fact that, without those signals and consensus, it cannot in itself function so as to perform a specific application\u201d.<\/p>\n

    That also means that a robot, even with its end effector, if it needs signals, for example, from a press, it is a PCM since, without those signals, it stands still.<\/p>\n

     <\/p>\n<\/div> <\/div>\n \n \n

    <\/div>\n \n\n <\/div>\n <\/section>\n\n \n\n\n\n\n \n \n \n\n\n\n\n \n \n \n
    \n\n \n\n
    \n \n \n
    \n \n \n

    \n The new definition of “Manufacturer” <\/h2>\n <\/div>\n \n
    \n

    That is not in today Machinery directive and countries have developed their own interpretation. Modifications to already installed machineries are a problem for the user, since no manufacturer wants to bear the responsibility of the parts he did not modify.<\/p>\n

    The definition of Manufacturer also changes. At the moment, according to a strict interpretation of the Definition, a manufacturer has to physically construct the machinery. With the new definition, a manufacturer can also have the machinery manufactured by somebody else. In other terms, anybody can be a manufacturer, what is important is that he has the knowledge and the ability of giving instruction how the safety has to be implemented. He must have full control on the safety aspects of the machinery, production line or process: he\/she can then be a manufacturer and CE mark the product.<\/p>\n

    [New M.P.R.] \u2013 Art. 3. Definitions<\/span><\/strong><\/p>\n

    (17) \u2018manufacturer\u2019 means any natural or legal person who manufactures machinery products or who has machinery products designed or manufactured, and markets those machinery products under his or her name or trademark or who designs and constructs machinery products for his or her own use;<\/span><\/p>\n

    [2006\/42\/EU] \u2013 Art. 2. Definitions<\/strong><\/span><\/p>\n

    (i) \u2018manufacturer\u2019 means any natural or legal person who designs and\/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer;<\/span><\/p>\n<\/div> <\/div>\n <\/div>\n \n \n <\/div>\n <\/section>\n\n \n\n\n\n\n \n \n \n

    \n\n \n\n
    \n \n \n
    \n \n \n

    \n Instructions\u00a0for use <\/h2>\n <\/div>\n \n
    \n

    There is not anymore the obligation to provide them in Paper format, unless the user asks for it.<\/p>\n

    [New M.P.R.] \u2013 5.1. Implementation plans and monitoring, evaluation and reporting arrangements<\/strong><\/p>\n

    \n

    Digital documentation: EHSRs 1.7.4 on instructions and Annex V on the manufacturer\u2019s declaration of conformity allow that manufacturers provide digital instructions and the declaration of conformity. Nevertheless, a paper format is mandatory upon request.<\/p>\n<\/blockquote>\n

    The obligation remains to provide them in one of the official languages<\/strong> \u200b\u200bof the country where the machinery is used.<\/p>\n

    [New M.P.R.] \u2013 Annex III: EHSR<\/strong><\/p>\n

    1.7. INFORMATION – 1.7.4. Instructions<\/strong><\/p>\n

    \n

    The instructions accompanying the machinery product shall be either \u2018Original instructions\u2019 or a \u2018Translation of the original instructions\u2019, in which case the translation shall be accompanied by the original instructions.<\/p>\n

    [\u2026]<\/p>\n

    (a) The instructions shall be drafted in one or more official languages of the Union. The words \u2018Original instructions\u2019 shall appear on the language version(s) verified by the manufacturer or his or her authorised representative;<\/p>\n<\/blockquote>\n

     <\/p>\n

    [2006\/42\/EU] \u2013 Annex I: EHSR<\/span><\/strong><\/p>\n

    1.7. INFORMATION – 1.7.4. Instructions<\/span><\/strong><\/p>\n

    \n

    All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and\/or put into service.<\/span><\/p>\n

    The instructions accompanying the machinery must be either \u2018Original instructions\u2019 or a \u2018Translation of the original instructions\u2019, in which case the translation must be accompanied by the original instructions.<\/span><\/p>\n<\/blockquote>\n<\/div> <\/div>\n <\/div>\n \n \n <\/div>\n <\/section>\n\n \n","protected":false},"excerpt":{"rendered":"

    The key objective of the new Regulation is to clarify and future-proof legislation in EU<\/p>\n","protected":false},"author":1,"featured_media":41954,"parent":1925,"menu_order":0,"template":"","meta":{"_acf_changed":false,"footnotes":""},"tipologia_approfondimento":[46],"class_list":["post-28846","approfondimento","type-approfondimento","status-publish","has-post-thumbnail","hentry","tipologia_approfondimento-machinery-directive"],"acf":{"sottotitolo":"","allegati":[{"string_block":"Regulation Machinery","file_block":28734},{"string_block":"Regulation Annex Machinery","file_block":28731}]},"yoast_head":"\nTHE MAIN CHANGES<\/title>\n<meta name=\"description\" content=\"...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.gt-engineering.it\/en\/insights\/machinery-directive\/machinery-product-regulation\/nuovo-regolamento-macchine-principali-modifiche-2\/\" 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