Technical File
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A Technical File (TF) contains relevant information demonstrating that your product complies with the essential requirements as outlined in the relevant directives and regulations. It is a mandatory component of proving the conformity of your product. As your full-service compliance partner, Certification Experts can assist you in gathering all necessary information and compiling the Technical File or Technical Documentation. With over 25 years of experience, you can trust us to demonstrate the conformity of your product, enabling you to market it in the desired market.
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What is a Technical File or what is Technical Documentation?
The terms “Technical File” and “Technical Documentation” are used in the context of regulatory compliance, particularly in fields like product certification and CE marking. The term “Technical Documentation” is used within the newer directives and regulation.
What was previously called the Technical Construction File and is now primarily referred to simply as the Technical File or Technical Documentation is essentially a compilation of all relevant information demonstrating compliance with the essential requirements of the applicable directives and/or regulations during the production of your product. This includes all documents and calculations used to design and build the product. The Technical File must remain available to the competent authorities of the member states for at least ten years from the construction date of the product (such as machine, toys, medical device) or, in the case of serial production, from the date of production of the last product. For the manufacturer, their Authorised Representative, or the importer, the Technical Documentation also serves as technical evidence that may provide defense possibilities in liability claims.
One should be cautious with compiling a Technical File, as it varies by product group. Examples of products for which Technical Files take different forms include:
- Technical file for Machinery Directive
- Technical file for electricity
- Technical file for medical devices
- Technical file for CE
The content of the Technical File is determined in accordance with the respective products for each directive and regulation.
Contents of the Technical File
Despite the variations within the content of the Technical File and content of the technical construction files for the different product groups, there is a general list of documents that essentially form a Technical File Checklist. This includes:
- A general description of the product
- Risk Assessment to determine applicable safety and health requirements for the product
- Design and manufacturing drawings
- Detailed technical data on essential aspects of the product
- A list of standards and essential requirements complied with
- Documentation of performed calculations and tests
- If applicable, certificates and inspection reports
- User information, including manuals, labeling, and packaging.
- If applicable, internal provisions adhered to ensure compliance with the directives and/or regaulations
This Technical File Checklist provides a solid foundation for preparing your Technical File, but the specific guidelines for your product dictate the final content of the Technical Documentation.
Additionally, it is important to regularly review and update the Technical File Checklist to ensure that your Technical File remains current and complies with all relevant requirements.”
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Creating a Technical File: a Practical Example.
Drafting Technical Documentation is a crucial step to demonstrate a product’s compliance with applicable directives and/or regulations. Here, we provide a practical example to guide you in preparing a Technical File.
These practical steps provide a solid foundation for preparing a Technical File. However, it is crucial to consult the specific guidelines for your product category and applicable directives and/or regulations to ensure that your Technical Documentation fully complies with the requirements. Keep the file regularly updated and conduct systematic checks to ensure ongoing compliance.
Technical File with Certification Experts
Certification Experts can assist you in gathering the necessary information and preparing the required Technical Documentation for you. Additionally, the documentation will be promptly checked for inaccuracies. We will guide you through the entire process and handle the following tasks on your behalf:
- Evaluating and guiding with preparing the manual and other user information.
- Compile a list of applied standards and the essential requirements.
- Evaluating, guiding, and preparing the Risk Assessment.
- Assembling the Technical File.
- Verifying the Technical File/Technical Documentation.
- Drafting a template for the EC/EU Declaration of Conformity (DoC).
- Carrying out calculations, testing and assessments.
- Providing neccesary certificates and inspection reports from third parties
- Set-up a Quality Management System
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All the answers you might need!
A Technical Construction File (TCF) is essentially the old term for a Technical File for the Machinery Directive—a document containing essential technical information about a machine. It is often required during the conformity assessment of machines, particularly in the context of European regulations, the CE marking. The purpose of a Technical Construction File is to demonstrate that the machine or installation complies with applicable technical specifications, standards, and safety requirements. The content of the Technical Construction File can be prepared based on a Technical Construction File checklist. This checklist includes a list of all the necessary documentation to complete the Technical Construction File, thereby demonstrating conformity. If you have similar machines, the content of the first Technical Construction File can serve as an example for subsequent machines.
A Technical File (TF), or Technical Documentation, is essentially a compilation of all relevant information demonstrating compliance with the essential requirements of the applicable directives and regulations during the production of your product. This includes all documents and calculations used to design and build the product. Technical Documentation CE vary for different product groups.
A Technical File or Technical Documentation is a comprehensive set of documents that demonstrate a product’s compliance with regulations and standards. The specific contents vary based on the product type and applicable regulations, but generally include technical specifications, Risk Assessments, conformity statements, test reports, manuals, certificates, information on materials and production, traceability details, a Declaration of Conformity, packaging information, and legal documents. It is crucial to tailor the Technical File to meet specific regulatory requirements.
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