{"product_id":"vasentlig-maskinandring-2027-artikel18-gransdragning","title":"Substantial machine modification 2027 – Article 3.16, manufacturer responsibility \u0026 CE | Word\/PDF\/Excel","description":"\u003csection lang=\"sv\" class=\"mb-product-description\" style=\"line-height:1.68;color:#153B59\"\u003e\n\u003cp\u003e\u003cstrong\u003eWill your company become the legal manufacturer when an older machine is converted, fitted with a new safety PLC, or given a modified robot function?\u003c\/strong\u003e The new EU Machinery Regulation \u003cstrong\u003e(EU) 2023\/1230\u003c\/strong\u003e contains specific rules on \u003cstrong\u003esubstantial modification\u003c\/strong\u003e in Article 3.16 and the manufacturer’s obligations for the person who makes the modification in Article 18. The main rules are due to apply from \u003cstrong\u003e20 January 2027\u003c\/strong\u003e. This niche document package helps machine owners, industrial maintenance and automation companies make a \u003cstrong\u003etraceable assessment of the boundary before a modified machine is put into service\u003c\/strong\u003e.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eImportant legal nuance:\u003c\/strong\u003e A major repair, component replacement, or digital software update is \u003cstrong\u003enot automatically\u003c\/strong\u003e a substantial modification. Article 3.16 sets out several conditions that must be assessed together. A substantial modification may occur when a physical or digital intervention after the machine has been placed on the market or put into service was not foreseen\/intended by the manufacturer, creates a new hazard or increases an existing risk, and leads to certain specifically stated additional protective measures or changes to the safety control system. Each step requires factual evidence.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eFiles in the package:\u003c\/strong\u003e Five Swedish working documents, one Swedish user guide, and one English User Guide – each in editable Word (DOCX) and searchable\/printable A4 PDF format. Also included is an Excel register with nine tabs and \u003cstrong\u003e759 administrative formulas\u003c\/strong\u003e. Total \u003cstrong\u003e7 DOCX + 7 PDF + 1 XLSX = 15 customer files\u003c\/strong\u003e for a one-time price of SEK 79. The PDF versions do not contain interactive form fields. The product is a digital ZIP-based document template, not a completed CE certification.\u003c\/p\u003e\n\n\u003cdiv style=\"border:2px solid #B7D5E5;border-left:6px solid #2B729C;background:#ECF6FB;border-radius:10px;padding:18px 20px;margin:19px 0\"\u003e\n\n\u003ch2 style=\"margin:0 0 9px;color:#1F587B\"\u003e01 · Package Contents\u003c\/h2\u003e\n\n\u003cp style=\"margin:0\"\u003eFive Swedish templates: \u003cstrong\u003emodification request, Article 3.16 criterion test, risk and safety function analysis, Article 18 manufacturer’s obligations\/CE pathway, and modification and commissioning log\u003c\/strong\u003e. Also included are Swedish and English user guides. All seven documents are provided in Word and searchable PDF, supplemented by Excel for traceable follow-up. 15 files in total, but seven independent documents.\u003c\/p\u003e\n\n\n\u003c\/div\u003e\n\n\u003cdiv style=\"border:2px solid #B7D5E5;border-left:6px solid #2B729C;background:#ECF6FB;border-radius:10px;padding:18px 20px;margin:19px 0\"\u003e\n\n\u003ch2 style=\"margin:0 0 9px;color:#1F587B\"\u003e02 · What the Files Contain\u003c\/h2\u003e\n\n\u003cp style=\"margin:0\"\u003eFields for the original machine and intended use, physical\/digital modification, manufacturer’s instructions, new or increased risks, protective devices, safety control, stability, and the affected part of the machine line. Separate checks for the professional modifier, possible manufacturer’s obligations, technical file, procedure under Article 25, evidence of testing, and competent decision. \u003cstrong\u003eExcel never issues CE marking, manufacturer’s declaration, or commissioning authorization.\u003c\/strong\u003e\u003c\/p\u003e\n\n\n\u003c\/div\u003e\n\n\u003ch2\u003eWhich Companies and Modifications Is the Product Suitable For?\u003c\/h2\u003e\n\n\u003cp\u003eIndustrial companies converting production lines, automation technicians changing PLCs or safety circuits, maintenance departments, workshops, system integrators, and machine builders with existing machines. The package is particularly relevant for \u003cstrong\u003erobot cell conversion, new safety functions, increased speed, or modified mechanical design\u003c\/strong\u003e when responsibility may be unclear between the machine owner, original manufacturer, and modifying contractor.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eExceptions and Boundaries:\u003c\/strong\u003e The regulation applies to products within its scope; previous market status and old rules must be mapped separately. Article 18 contains an express exemption from manufacturer status for a \u003cstrong\u003enon-professional user who modifies their own machine for their own use\u003c\/strong\u003e. The exemption does not automatically remove other safety and liability requirements.\u003c\/p\u003e\n\n\u003ch2\u003eComplete File List – 15 Files\u003c\/h2\u003e\n\n\u003cdiv style=\"overflow-x:auto\"\u003e\u003ctable style=\"width:100%;min-width:680px;border-collapse:collapse\"\u003e\n\n\u003cthead\u003e\u003ctr style=\"background:#DFEDF5\"\u003e\n\n\u003cth style=\"padding:8px;text-align:left\"\u003eWorking Template\/File\u003c\/th\u003e\n\n\u003cth style=\"padding:8px;text-align:left\"\u003eWhat You Can Document\u003c\/th\u003e\n\n\u003cth style=\"padding:8px;text-align:left\"\u003eLanguage\/Format\u003c\/th\u003e\n\n\n\u003c\/tr\u003e\u003c\/thead\u003e\n\n\u003ctbody\u003e\n\n\u003ctr\u003e\n\n\u003ctd\u003e01 Machine Inventory and Modification Request\u003c\/td\u003e\n\n\u003ctd\u003eOriginal machine, model, serial number, history, risk boundaries, and actual conversion assignment.\u003c\/td\u003e\n\n\u003ctd\u003eSV · DOCX and PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003ctd\u003e02 Article 3.16 – Substantial Modification\u003c\/td\u003e\n\n\u003ctd\u003eTest of each cumulative condition: after market\/use, not intended by the manufacturer, increased risk, and special protection.\u003c\/td\u003e\n\n\u003ctd\u003eSV · DOCX and PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003ctd\u003e03 Risk and Safety Function Analysis\u003c\/td\u003e\n\n\u003ctd\u003eNew hazards, protection, safety PLC, stability, strength, testing, and expert evidence.\u003c\/td\u003e\n\n\u003ctd\u003eSV · DOCX and PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003ctd\u003e04 Article 18, CE Pathway, and Manufacturer’s Obligations\u003c\/td\u003e\n\n\u003ctd\u003eWhether the person who makes the modification can be considered the manufacturer, responsible machine\/part, and formal procedure under Articles 10 and 25.\u003c\/td\u003e\n\n\u003ctd\u003eSV · DOCX and PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003ctd\u003e05 Modification Log and Commissioning Decision\u003c\/td\u003e\n\n\u003ctd\u003eVersions, technical test results, document chain, open non-conformities, and separate decision-making authority.\u003c\/td\u003e\n\n\u003ctd\u003eSV · DOCX and PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003ctd\u003e06 Swedish User Guide\u003c\/td\u003e\n\n\u003ctd\u003eSix-step workflow, dates, technical risks, and legal caveats.\u003c\/td\u003e\n\n\u003ctd\u003eSV · DOCX and PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003ctd\u003e07 English User Guide\u003c\/td\u003e\n\n\u003ctd\u003eInstructions for the Swedish operational templates, not a full English translation of the five forms.\u003c\/td\u003e\n\n\u003ctd\u003eEN · DOCX and PDF\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\u003ctr\u003e\n\n\u003ctd\u003e08 Excel – Risk and Issue Register\u003c\/td\u003e\n\n\u003ctd\u003eNine tabs for machines, modifications, risks, Article 18, testing, measures, and sources.\u003c\/td\u003e\n\n\u003ctd\u003eSV · XLSX\u003c\/td\u003e\n\n\n\u003c\/tr\u003e\n\n\n\u003c\/tbody\u003e\n\n\n\u003c\/table\u003e\u003c\/div\u003e\n\n\u003ch2\u003eExcel with Nine Tabs and 759 Formulas\u003c\/h2\u003e\n\n\u003cp\u003eThe nine tabs are named \u003cstrong\u003eRead Me, Overview, Machines, Modifications, Risks, Article18, Testing, Measures, and Sources\u003c\/strong\u003e. The overview counts actual modification cases, risk items, the need for expert review, and open measures. Formulas may display “INVESTIGATE CONDITIONS,” “TO ART 3.16 EXPERT REVIEW,” “PROTECTION REVIEW,” “TO MANUFACTURER REVIEW,” “TEST PRIVATE EXEMPTION,” “STOP – ERROR,” “RETEST REQUIRED,” and “TO MANUAL FINAL CHECK.”\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003e29 out of 29 functional tests passed\u003c\/strong\u003e after data from actual scenarios were entered into a separate QA copy: including software updates foreseen by the manufacturer, new hazards, modified safety control systems, professional modifiers, own-use exemptions, and remaining testing errors. The customer’s workbook contains \u003cstrong\u003eno QA issues\u003c\/strong\u003e. All form statuses require a substantive manual assessment; no formula can prove that a modification is substantial or that a machine is safe.\u003c\/p\u003e\n\n\u003ch2\u003ePractical Workflow Before Machine Conversion\u003c\/h2\u003e\n\n\u003col\u003e\n\n\u003cli\u003e\n\n\u003cstrong\u003eIdentify the machine:\u003c\/strong\u003e check the original manufacturer, product category, year of manufacture, date of market\/commissioning, and original regulatory framework.\u003c\/li\u003e\n\n\u003cli\u003e\n\n\u003cstrong\u003eDescribe the modification:\u003c\/strong\u003e document the physical\/digital change, version, intended function, and whether the modification was planned\/foreseen by the manufacturer.\u003c\/li\u003e\n\n\u003cli\u003e\n\n\u003cstrong\u003eTest Article 3.16:\u003c\/strong\u003e identify new hazards\/increased risk and whether a new protective device is required with a change to the existing safety control system or additional protection for stability\/mechanical strength.\u003c\/li\u003e\n\n\u003cli\u003e\n\n\u003cstrong\u003eConduct a qualified risk analysis:\u003c\/strong\u003e also assess affected machine parts and interfaces in a combined machine; retain drawings, version history, and technical verification.\u003c\/li\u003e\n\n\u003cli\u003e\n\n\u003cstrong\u003eAddress Article 18:\u003c\/strong\u003e a professional modifier may incur the manufacturer’s obligations under Article 10, including relevant technical documentation and the applicable conformity procedure under Article 25. Exemptions for private, non-professional own use should be assessed separately.\u003c\/li\u003e\n\n\u003cli\u003e\n\n\u003cstrong\u003ePerform actual testing:\u003c\/strong\u003e document safety functions, tests, and errors. Article 25 and Annex I may in some cases require a notified body.\u003c\/li\u003e\n\n\u003cli\u003e\n\n\u003cstrong\u003eMake a formal decision outside Excel:\u003c\/strong\u003e only a competent responsible person may make a decision on commissioning after applicable product and operational safety has been assessed.\u003c\/li\u003e\n\n\n\u003c\/ol\u003e\n\n\u003ch2\u003eWhat Does a Substantial Modification Mean Under EU 2023\/1230?\u003c\/h2\u003e\n\n\u003cp\u003e\u003cstrong\u003eArticle 3.16:\u003c\/strong\u003e the definition is based on a number of interrelated conditions. It is not enough for a modification to be expensive or extensive. In particular, it must be assessed whether the intervention was not foreseen\/intended by the original manufacturer, affects safety through a new hazard or increased existing risk, and requires the specifically defined additional protective measures. \u003ca href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SV\/TXT\/?uri=CELEX:32023R1230\"\u003eRead the official regulation.\u003c\/a\u003e\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eArticle 18:\u003c\/strong\u003e the person who carries out a substantial modification may be considered the manufacturer and incur obligations under Article 10. For a combined machine, depending on the risk analysis, the obligations may need to be delimited to a specific machine or part. A non-professional user who modifies for their own use is expressly exempt from this Article 18 responsibility. \u003ca href=\"https:\/\/www.av.se\/arbetsmiljoarbete-och-inspektioner\/inspektioner-utredningar-och-kontroller\/produktregler-och-marknadskontroll\/produktregler\/krav-pa-maskiner\/den-nya-maskinforordningen\/\"\u003eSwedish Work Environment Authority guidance.\u003c\/a\u003e\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eArticle 25 and Annexes I\/III:\u003c\/strong\u003e the responsible person must follow a relevant procedure for assessing conformity. An external notified body may be required for certain categories. This package is neither an EU declaration of conformity, a CE mark, nor a technical control certificate.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eNational Swedish Supplement:\u003c\/strong\u003e Ds 2026:16 describes proposed supplementary Swedish regulations, with the proposed entry into force on 20 January 2027. \u003cstrong\u003eAs of 9 November 2026, this is a preparatory proposal, not yet decided Swedish law.\u003c\/strong\u003e \u003ca href=\"https:\/\/www.riksdagen.se\/sv\/dokument-och-lagar\/dokument\/departementsserien\/anpassningar-av-svensk-ratt-till-eus_heb416\/html\/\"\u003eRead Ds 2026:16.\u003c\/a\u003e\u003c\/p\u003e\n\n\u003ch2\u003eDifference from Mallbutikens Existing Products\u003c\/h2\u003e\n\n\u003cp\u003e\u003ca href=\"\/en\/products\/eu-maskinforordningen-machinery-regulation-2027-riskbedomning-ce-technical-file-word-pdf-excel\"\u003eEU Machinery Regulation 2027 – Risk Assessment, CE \u0026amp; Technical File\u003c\/a\u003e is a broad product for the new machinery regulation’s product requirements. This niche, instead, deals with a single concrete moment of work: \u003cstrong\u003eis a certain modification of an existing machine legally substantial, and who becomes responsible for the safety and manufacturer’s assessment?\u003c\/strong\u003e \u003ca href=\"\/en\/products\/maskinregister-forebyggande-underhall-excel-2026-2027\"\u003eMachine Register \u0026amp; Preventive Maintenance\u003c\/a\u003e also has a different scope.\u003c\/p\u003e\n\n\u003ch2\u003eFrequently Asked Questions\u003c\/h2\u003e\n\n\u003ch3\u003eWill all modified machines be CE marked again from 2027?\u003c\/h3\u003e\n\n\u003cp\u003eNo. A new CE and manufacturer’s assessment may become relevant when the relevant conditions are met. It is not a rule for the automatic re-marking of all older machines.\u003c\/p\u003e\n\n\u003ch3\u003eIs a new PLC or software version always a substantial modification?\u003c\/h3\u003e\n\n\u003cp\u003eNo. Digital changes may also be covered, but Article 3.16 contains several interrelated criteria that must be documented and assessed.\u003c\/p\u003e\n\n\u003ch3\u003eCan a maintenance contractor become the legal manufacturer?\u003c\/h3\u003e\n\n\u003cp\u003eYes, this may occur if the contractor carries out a substantial modification under Article 3.16 and falls under Article 18. It is determined by the actual circumstances, not solely by the title of the agreement.\u003c\/p\u003e\n\n\u003ch3\u003eWhat applies when only one machine in a larger production line is modified?\u003c\/h3\u003e\n\n\u003cp\u003eArticle 18 allows for a risk-assessment-based delimitation to the affected machine or related product. Investigate the interfaces with other parts before the scope is determined.\u003c\/p\u003e\n\n\u003ch3\u003eCan a private individual who modifies their own machine become the manufacturer under Article 18?\u003c\/h3\u003e\n\n\u003cp\u003eThe provision contains an express exemption for non-professional users who modify their own machine for their own use. This does not generally mean that no other safety rules apply.\u003c\/p\u003e\n\n\u003ch3\u003eCan Excel provide CE approval?\u003c\/h3\u003e\n\n\u003cp\u003eNo. Excel can only show administrative deficiencies, risk flags, and the need for further expert review. None of the files issue technical or legal approval.\u003c\/p\u003e\n\n\u003ch3\u003eAre the product’s PDF files digitally fillable?\u003c\/h3\u003e\n\n\u003cp\u003eNo. They are searchable and printable A4 copies. Fill in and customize the Word versions.\u003c\/p\u003e\n\n\u003ch3\u003eIs translation of all main templates into English included?\u003c\/h3\u003e\n\n\u003cp\u003eNo. The five working templates, Swedish guide, and Excel are in Swedish. A separate English User Guide describes the use of these templates in English.\u003c\/p\u003e\n\n\u003ch2\u003eOfficial Sources and Quality Status\u003c\/h2\u003e\n\n\u003cp\u003ePrimary sources: \u003ca href=\"https:\/\/eur-lex.europa.eu\/legal-content\/SV\/TXT\/?uri=CELEX:32023R1230\"\u003eEU Regulation 2023\/1230\u003c\/a\u003e, especially Articles 2, 3.16, 10, 18, and 25, Annexes I and III; \u003ca href=\"https:\/\/www.av.se\/arbetsmiljoarbete-och-inspektioner\/inspektioner-utredningar-och-kontroller\/produktregler-och-marknadskontroll\/produktregler\/krav-pa-maskiner\/den-nya-maskinforordningen\/\"\u003eSwedish Work Environment Authority – The New Machinery Regulation\u003c\/a\u003e; \u003ca href=\"https:\/\/www.riksdagen.se\/sv\/dokument-och-lagar\/dokument\/departementsserien\/anpassningar-av-svensk-ratt-till-eus_heb416\/html\/\"\u003eDs 2026:16\u003c\/a\u003e on proposed Swedish supplements.\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eVersion 1.0, AI-assisted legal source check and technical QA November 9, 2026.\u003c\/strong\u003e No external lawyer, machine safety expert, competent technical inspector, authority, or notified body has reviewed or approved the package. The files’ formulas have been tested with 29 scenarios but not with actual CE testing or real industrial machines. \u003cstrong\u003eThis template cannot independently demonstrate or guarantee regulatory compliance.\u003c\/strong\u003e\u003c\/p\u003e\n\n\u003c\/section\u003e","brand":"Svenska Dokumentmallar","offers":[{"title":"Default Title","offer_id":56558930461014,"sku":"MB-MASKIN-ANDRING-2027-V1","price":79.0,"currency_code":"SEK","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0827\/2373\/3846\/files\/mallbutiken-01_MaskinAndring_Huvudbild_1600.png?v=1794223074","url":"https:\/\/mallbutiken.se\/en\/products\/vasentlig-maskinandring-2027-artikel18-gransdragning","provider":"Mallbutiken","version":"1.0","type":"link"}