We will provide you with your entire technical documentation for CE marking acc. to current and relevant laws, standards, applicable product standards and directives. Functional and law-compliant. We will support you with your technical documentation for CE marking just as you need us. For partial projects or for your entire technical documentation for CE marking. For the systems you built yourself, for redesign and for your products.
Why do you need technical documentation for CE marking?
For this question, you will surely get a different answer from you legal department than from your Purchasing or Sales/Marketing team. Laws and regulation in the EU require complete technical documentation. Faulty and non-compliant technical documentation will in case of damage result in fines and penalties acc. to the (German) Product Liability Act, Civil Code (Bürgerliches Gesetzbuch, BGB) and, if applicable, contract law. Therefore, law-compliant technical documentation is a must for the legal department.
Purchasing needs clear specifications about the requirements for components by suppliers. A well-structured technical documentation provides the team with all answers they need.
For Sales/Marketing, customer-attracting aspects are of main interest. The part of the technical documentation delivered to the client with the product must have an appealing, clearly arranged layout, be understandable, be user-friendly, comply with all applicable standards/directives/laws, etc. If you use the machine/production line for your own needs, your employees will also appreciate an unambiguous current technical documentation.
Technical Documentation for Machines and Production Lines
The Machinery Directive 2006/42/EC is the central “reference book” for your technical documentation. The Machinery Directive requires that the manufacturer creates the technical documentation before issuing the EC declaration of conformity. This way, the manufacturer can prove the conformity of his product and/or system of own design. It must present an image of all life phases of the product, from design to disposal. In this, the manufacturer must always keep the protection aims and state-of-the-art technology in mind in order to meet all requirements to safety, environment and health protection for safe use of the machine/system as intended. Upon request, the manufacturer must present the technical documentation to the market supervision authorities after the system is on the market.
The technical documentation for CE marking acc. to Machinery Directive must at least include the following:
- a general description of the machine with the machine limits
- drawings, results of checks/tests etc.
- documentation of the Risk Assessment
- Applied standards
- Operating instructions or instructions for use, user manual, etc.
- if applicable, declaration of incorporation or EU/EC declaration of conformity for supplier components
- EC Declaration of Conformity
You are not sure whether your technical documentation is complete or if your product is covered by the Machinery Directive or possibly under another directive? Please call us. We are happy to advise you on which technical documentation you need for which EU directive.
Translation of the original operating instructions for CE marking
The EU Machinery Directive 2006/42/EC requires that the operating instructions are translated if a machine is exported into another country of the community. A translation must be done into one or several official languages of the community.
DIN EN 82079-1, Preparation of instructions for use – Structuring, content and presentation – Part 1: General principles and detailed requirements (replaces DIN EN 62079) deals with the quality of translations. This standard also requires a quality standard for the technical translation. If the operating instructions are translated from the original language into another language, a specialised translator or a specialist must be responsible for the translation. Requirements to specialists for technical translation include:
- competence in technical communication
- knowledge of the subject field
- native speaker of the target language or fluency in both source and target language
- If the translation is edited, that task shall also only be done by specialists for target-oriented writing and translation.
Important for the technical translation of your documentation: For the translation, the same rules apply as for the original. The operating instructions must be understandable and their contents correct, they must describe the functionality of the product and reply to all questions regarding WHERE? WHO? WHAT? WHEN? HOW? WHY? The technical translation must reflect all information of the original operating instructions. You can only achieve this by a precise and qualified translation.
With us, the technical translation of your documentation is in good hands. Our specialised translators have the required technical competence and as native speakers also the necessary feel for the language to translate your documentation efficiently and correctly. Please ask us for more information about what we can do for you.