The technical file is the evidence supporting your declaration of conformity. Without a file, that declaration is a claim you cannot substantiate. A supervisory authority or a buyer can request it. You must then be able to show the basis of your declaration within the legal timeframe. <\/p>\n\n
The technical file is the substantiation for your declaration of conformity. You declare that your product complies. The file is the evidence with which you can substantiate that declaration. Without a file, the declaration is merely a claim. <\/p>\n\n
That distinction only becomes visible the moment someone asks for it. This could be a supervisory authority, but in practice, it is more often a buyer or a marketplace requesting it before listing your product. <\/p>\n\n
A technical file contains a description of the product, the design drawings, a risk assessment, the applied standards, the test reports, the instructions for use, and the declaration of conformity itself. The composition varies per regulation, but these components are found in almost every file. Keep them together so you can present them all at once. <\/p>\n\n
The exact content varies per regulation, but the core is the same everywhere. These components are found in almost every file: <\/p>\n\n
| Product category<\/th> | Retention period<\/th> | From<\/th><\/tr> <\/thead> |
|---|---|---|
| General consumer products<\/td> | 10 years<\/td> | Last item placed on the market<\/td><\/tr> |
| Machinery<\/td> | 10 years<\/td> | Last item placed on the market<\/td><\/tr> |
| Personal protective equipment<\/td> | 10 years<\/td> | Last item placed on the market<\/td><\/tr> <\/tbody> <\/table>How long you must keep it<\/h2>\n\nYou must keep the technical file for ten years, calculated from the moment you placed the last item on the market. So, not from the production date and not from the first sale. If you modify the product, that period starts again for that version. <\/p>\n\n The general rule is ten years, calculated from the moment you placed the last item on the market. Not from the production date. Also not from the first sale. <\/p>\n \n\tNote regarding product modifications<\/b>\n\t If you change something about the product, the period starts again for that version. In practice, this means: keep a separate file for each model variant. Not one single file for a series that has been adapted over the years. <\/p>\n<\/div>\n\n What usually goes wrong<\/h2>\n\nThe most common mistake is a file that appears complete but does not belong to the product actually being sold. This happens as soon as a supplier adapts the design without the documentation being updated. The test report then belongs to an earlier version. <\/p>\n\n The most common mistake is a file that appears complete but does not belong to the product actually being sold. This happens if a supplier adapts the design without the documentation being updated. <\/p>\n\n
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