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Regulation (EU) 2023/988 · Article 16
The file an authority asks for, and the ten days you have to produce it.
Article 16 does not only require a name on a label. It requires that someone inside the Union holds the technical documentation and can hand it over when asked, which is a very different commitment from renting an address.
What the file contains
A general description of the product, its essential characteristics, an analysis of the possible risks and the measures taken against them, plus the test reports or standards relied on.
For most consumer goods this is a modest folder, not a research archive — but it has to exist before it is requested, because it cannot be assembled convincingly afterwards.
How long it must be kept
Ten years from the moment the product is placed on the market. That outlasts most suppliers, most product lines and quite a few companies, which is why the storage arrangement matters as much as the content.
If your responsible person disappears, the obligation to produce the file does not.
Who actually holds it
The manufacturer prepares it; the responsible person must be able to make it available to authorities on a reasoned request. In practice that means either holding a copy or having guaranteed, immediate access to one.
We hold the mandate and the declaration of conformity, and we agree in writing how the rest of the file is reached, so a request never depends on you being awake in another time zone.
What the designation gives you
A written mandate under Article 16, our name and address formatted for your packaging and your listing, and a verification code that resolves on a public register while the mandate is live.
Nothing here is a PDF you have to be trusted about. The code is the proof, and it works for anyone who scans it.
Proof, not paperwork
A compliance file is only worth what a stranger can confirm about it without asking you first.
That is why the appointment carries a public code rather than a signature you would have to vouch for.
Questions we are asked
Do you write my technical file for me?
We review it and tell you what is missing on the plans that include a review. Preparing it is the manufacturer's obligation, and no provider can lawfully take that over for you.
What happens if the file is incomplete when an authority asks?
The request does not go away. Authorities can require corrective measures, withdrawal or a recall while the gap is open, so the cost of an incomplete file is measured in stopped sales.
Ten years is a long time. Where is it stored?
Documents we hold are kept for the full retention period independently of the subscription, and remain retrievable by you and by an authority for as long as the law requires.
The label gets you listed. The file is what keeps you listed when someone decides to look properly.
Appoint us and put the block on your label today
Designation is issued the same working day the form and payment are complete. Unlimited products on every plan.
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