In many cases, you will need a Technical Compliance File (TCF) to operate as a merchant (importer or Amazon seller) in the European Union. Your TCF is a collection of documents and details demonstrating that your products meet the set requirements and quality standards. Failure to produce a TCF will result in expensive fines and recalls. 

This post will give you some guidance on what to include in your TCF as well as how AQF’s solution allows you to handle all the necessary documents in one platform.

Documents & Details to Include in a Technical Compliance File

First things first, what goes into a Technical Compliance File and what documents will you need to include? A TCF will ideally include all details regarding a product's overall quality. Importers and manufacturers should already have these documents on hand as part of their product specifications, so it is just a matter of organizing them into a properly structured technical file. 

It is worth noting that the nature and number of these documents depend on the type of product. Some products (such as medical devices) may require more documents and details than others. 

Technical File Requirements For European Importers CTA

Manual vs. Automated Creation

Usually, responsibility for getting these documents and creating a Technical Compliance File goes to the importer or seller. Additionally, mistakes with the file (regardless of how minute) will get it flagged and rejected, delaying your product's entry into the EU market. 

For example, the file should be formatted in a particular order, prioritizing certain files and details over others. Additionally, each file's content should also be formatted in a particular style, and the authorities update these rules and requirements periodically. 

Unsurprisingly, creating a Technical Compliance File manually can prove complicated. As such, most merchants and importers prefer using an automated program. Automated programs are fast and will save you a lot of work and time – they are also easy to use and accurate. 

How Does an Automated Program Work

An automated technical file creation program is pre-programmed according to the EU's (and other relevant authorities') standards and requirements. The program automatically formats the data so that it is compliant with the requirements. 

Ideally, an automated software will ask for data relevant to the product/service when creating the document. Some of the details required include: 

  • Article (file) name and number. 
  • The supplier's contact details. 
  • The type and category of product/service. 
  • The countries on your market list. 

The program will ask many questions regarding the product or service, including whether or not it is packaged. It is advisable to be as detailed and clear as possible. Additionally, it is important to update the program regularly – at least as regularly as the EU updates its TCF's requirements

Most programs also allow users to customize the file according to their preferences. For example, you can choose whether or not to monitor the social compliance aspects of your partners in the supply chain. However, it is worth noting that different programs have varying features and capabilities. 

More Than Regulatory Compliance

It is crucial to ensure that your Technical Compliance File contains all the details and documents required by the authorities. More importantly, it is crucial to test and inspect your products thoroughly to ensure that they meet the requirements. 

AQF’s Technical Compliance File solution provides visibility into file progress, consumer satisfaction, and one-click documentation sharing with authorities. Your technical compliance file (TCF) will be available for up to 10 years. We also establish procedures, define the scope of compliance, and help determine any additional quality and safety criteria. 


Get in touch today to learn more. 


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