EU/CE Technical File Structure Templates

Technical File Templates

These templates for the technical file help you to gather and structure all your documentation to prove compliance with the requirements. The structure is set up according to the legal requirements on the contents of a technical file and years and years of best practices.  Keep your technical file from being a jumbled mess with out proven templates

PLEASE NOTE: These templates for the technical file structure do NOT contain all the documents needed for your product, as every product is unique. But the templates contain a folder structure to help you collect the right documents for your product type.

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A clear structure for your technical file

The technical file is the set of documents that describe a product, device or machine and demonstrate that the product or machine is designed in accordance with the requirements of the relevant directives and regulations.

All produtcs subject to CE marking must have a technical file containing the information to demonstrate that the product complies with CE directives and regulations.

But a technical file must also be created for all non-CE products to demonstrate conformity with other directives such as the General Product Safety Directive, REACH and the Packaging Directive.

The content of the technical file is determined by the relevant directives and regulations: the technical file of a machine (officially called the technical construction file) contains the parts as described in the machinery directive and the technical file of toys as laid down in the toys directive.

PLEASE NOTE: These templates for the technical file structure do NOT contain all the documents needed for your product, as every product is unique. But the templates contain a folder structure to help you collect the right documents for your product type.

Money-Back Guarantee

All our templates have a 14-day, no-reason-required guarantee. So if you are not satisfied, for any reason, just let us know and we’ll refund your money.

As we truly believe our product will help you create better technical files, we don’t think it’ll come to that.

But as soon as you have any doubts whether our technical file template is the right fit for you, just put your mind at ease. We will help you to get the results you want, or we will give you your money back!

Choose the template most suitable for your product

Below you will find the different templates for the vast majority of products that require a technical file. Not sure which template is most suitable for your product? We are here to help! Send us an email to info@instrktiv.com and we will respond within 24 hours.

Electrical Equipment

Template for the technical file for electrical and electronic products, structured according to the requirements from the EMC, low voltage, radio equipment and RoHS directive.

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Machinery

Template for the technical file for machinery to comply with the machinery directive 2006/42/EC.

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Partly Completed Machinery

Template for the technical file for partly completed machinery to comply with the machinery directive 2006/42/EC.

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Toys

Template for the technical file for toys to comply with the toy safety directive 2009/48/EU.

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Measuring instruments

Template for the technical file for measuring instruments to comply with directive 2014/32/EU on measuring instruments.

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Personal protective equipment

Template for the technical file for personal protective equipment to comply with regulation (EU) 2016/425 relating to personal protective equipment.

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General Product Safety

Template for the technical file for GPSD products. The general product safety directive is a so-called “catch all” directive and applies to all products that do not fall under specific product safety legislation.

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Construction Products

Template for the technical file for construction products to comply with regulation (EU) 305/2011 on construction products.

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Food Contact Materials

Template for the technical file for food contact material to comply with regulation (EC) No 1935/2004 on food contact materials.
Please note that different forms of food contact materials may also be covered by their own harmonised regulations, for example for ceramics, plastics. Also directives or regulations for electrical products, measuring equipment or others may apply.

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Medical Devices

Template for the technical file for medical devices to comply with regulation (EU) 2017/745 on medical devices.

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Non-automatic weighing instruments

Template for the technical file for non-automatic weighing instruments to comply with diredctive Directive 2014/31/EU on non-automatic weighing instruments.

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EU/CE Technical File Structure Templates

€49,90 test

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Frequently Asked Questions

The template is an MS Word file. To open our files you need Microsoft Word.
Yes! All our packages have a 14-day no-reason-required guarantee. So if there is any reason that you are not satisfied, just let us know and we’ll refund your money. As we think that our product really helps you to create better documentation, we don’t think it’ll come to that. But as soon as you have any doubts whether our product is the right fit for you, just put your mind at ease. We will help you to get the results you want, or we will give you your money back!
You can find the following important information on our website:
  • General business terms and conditions
  • Revocation statement
  • User manual template disclaimer
  • Website privacy policy
No! The User Manual Template is a tool that will HELP you to create compliant manuals. We will tell you what elements should be in the manual, how to comply with directives and standards and even provide you with ready-to-use legal texts, but in the end you are responsible for full compliance. There are hundreds of thousands of different products out there and they all come with different risks. So it is impossible to create a template that includes all warnings for all products for example. However, we do tell you HOW you should include your specific product information in order to achieve compliance. Besides that we have included many elements for the main product groups and requirements from standards like the ANSI Z535.6 and IEC/IEEE 82079-1:2019.
As soon as your payment has been completed, you will receive an email with a link to the download page. If you haven’t received an email after some time, please check your spam folder and junk mail. It might be in there! If you haven’t white listed us yet, please make sure you do so if you want to receive our updates on legislation changes, sample instruction manuals and other relevant stuff.
Legislation is subject to improvement and technological progress. That’s why safety standards and/or directives are being updated every now and then. Once part of our community, we send you updates on relevant changes.

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