Heinrich Knutas in einer Fertigungshalle

Guide to CE marking, machinery safety and the Machinery Regulation

Compiled by Heinrich Knutas · LinkedIn

I have been guiding CE projects in machinery, plant and special purpose engineering for years. Here I collect the questions that keep coming up in projects, with answers that hold up in daily practice. If you want to produce your documentation yourself, Kaidoc.app is the software for it. For linked lines, several manufacturers and contested assessment questions, Knutec.de takes the work on as an engineering service.

Frequently asked questions on law and regulationsImage to follow Frequently asked Frequently asked questions on law and regulations Deadline, transition, existing machinery, substantial modification, partly completed machinery: 15 questions on the legal framework, each answered directly. Frequently asked questions on CE marking and conformityImage to follow Frequently asked Frequently asked questions on CE marking and conformity Who may affix the CE marking, which steps the procedure involves, what has to go into the declaration of conformity: 11 questions from project practice. Frequently asked questions on risk assessmentImage to follow Frequently asked Frequently asked questions on risk assessment Procedure, evaluation, residual risks, documentation and updating: 14 questions on risk assessment to EN ISO 12100. Frequently asked questions about instructions for useImage to follow Frequently asked Frequently asked questions about instructions for use Mandatory content, digital provision, QR codes, language, warnings and residual risks: 8 questions on instructions for use. Frequently asked questions on technical documentationImage to follow Frequently asked Frequently asked questions on technical documentation What belongs in the technical file, what the customer receives, what stays internal, how long it has to be kept and in which language: 20 questions. How do you produce a risk assessment for a machine?Image to follow Risk assessment How do you produce a risk assessment for a machine? From the limits of the machine to documenting residual risks: the procedure in six steps, with the mistakes that happen most often. How does CE marking of machinery work?Image to follow CE & conformity How does CE marking of machinery work? The complete procedure in eight steps, from classifying the product through the risk assessment to the rating plate and keeping the documents. May I supply the instructions for use purely digitally from 2027?Image to follow Instructions for use May I supply the instructions for use purely digitally from 2027? Digital is the standard form from 2027, but tied to conditions. All requirements for QR code, availability and the paper version as a checklist. How are instructions for use structured? A template with an explanation of every chapterImage to follow Instructions for use How are instructions for use structured? A template with an explanation of every chapter The complete structure of original instructions for use: 11 chapters, 51 sections. Every heading comes with what belongs in it, plus typical content as an example. Which technical documentation does a machine need?Image to follow Technical documentation Which technical documentation does a machine need? What belongs in the technical file, who has to keep it available and for how long, including the line between the internal file and the documents supplied. How do you draw up an EU declaration of conformity?Image to follow CE & conformity How do you draw up an EU declaration of conformity? All mandatory content at a glance, the line to the declaration of incorporation and the mistakes that come up most often during market checks. Which CE documents do I have to hand over to the customer, and which stay internal?Image to follow Technical documentation Which CE documents do I have to hand over to the customer, and which stay internal? Mandatory are the instructions for use and the EU declaration of conformity. Risk assessment, calculations and test records stay in the technical file, with a clear line and an answer to customer demands. Which language do instructions for use and CE documents have to be in?Image to follow Instructions for use Which language do instructions for use and CE documents have to be in? Instructions for use, warnings and the declaration of conformity in the official language of the country of destination; project-specific documents and instructions for the manufacturer's own specialists may be in English. How does a risk assessment to EN ISO 12100 work?Image to follow Risk assessment How does a risk assessment to EN ISO 12100 work? The iterative process of the standard in detail: risk elements, risk graph, three-step method and the point at which a risk counts as adequately reduced.
Heinrich Knutas
Heinrich Knutas
Machinery safety engineer
Founder of Kaidoc.app · CEO of Knutec.de · LinkedIn

Has been guiding CE projects in machinery, plant and special purpose engineering for years. That work led to Kaidoc.app, a software for standards-based CE documentation. Through Knutec.de the same work is available as a personal service.

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The articles in this guide are produced with AI assistance and reviewed for technical accuracy before publication. Editorial responsibility within the meaning of Art. 50(4) of the AI Act (EU) 2024/1689 lies with Heinrich Knutas. The tile images are AI-generated illustrations; they do not show real machines, installations or people. The large image at the top of this page shows a real photograph of the author in front of an AI-generated background. The portrait in the author box is an unedited photograph.

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Instructions for use, risk assessment and EU declaration of conformity under Machinery Regulation (EU) 2023/1230. With Kaidoc.app you create the documents yourself, structured along the standards instead of copied together from past projects. If time is short, Knutec.de takes the project on as a service.
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