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What happens if I don't maintain a complaints register under GPSR?

Without an organized overview of complaints and reports about your products, you often miss the first signal of a problem — and you have nothing to show when a supervisor asks for it.

A complaints register is not a formality you can fill in retroactively. If you don't keep one, you often miss the first signal that something is structurally wrong with a product — and that signal typically comes from a customer, not from a laboratory. The consequence is that you respond later than necessary, that you cannot provide an overview when a supervisor asks, and that any recall action proceeds more slowly and messily than it would if you had known what was happening.

The regulation expects market participants to remain aware of signals about the safety of their products and to act on them. A complaints register is the practical tool to demonstrate this: who reported what, when, about which product, and what did you do about it. Without that register, that history does not exist on paper, even if you handled the complaint by telephone at the time and thought no more about it afterwards.

What the regulation actually expects

GPSR places a duty of care on manufacturers and, in adapted form, on other market participants as well, to continue monitoring product safety as long as the product is on the market. This means, among other things, that complaints, damage reports and recurring questions about a product must not disappear separately in your mailbox, but must be recognizable as a whole. The law does not prescribe the exact form of that register; what matters is the outcome: can you show at any time what has become known about a product.

The exact role you play in this — manufacturer, importer or something in between — determines how heavily that obligation weighs on you. Anyone who has not yet clarified this can do so have that clarified in a few questions before the rest of this section becomes relevant.

The risk of keeping nothing

Without a register, you run into three practical problems. First, you often see a pattern too late: one complaint is an incident, three complaints about the same part within a month is a signal — but you only see that signal if the complaints come together somewhere. Second, when a market supervisor asks, you cannot demonstrate that you have fulfilled your duty of care; this is not a guarantee of a penalty, but it makes a conversation with a supervisor considerably more difficult than if you can lay a clear overview on the table. Third, it delays any recall action: if you first have to find out who ever complained and about what, you lose time that you don't have in such a situation.

Moreover, it is not a matter of estimating the risk of detection — we deliberately leave that to the supervisor and your own lawyer. It is about something more straightforward: a register is inexpensive to maintain and expensive to have to reconstruct afterwards.

How it relates to the rest of your file

A complaints register does not stand alone from your risk analysis and technical documentation. A complaint that comes in can be reason to revise a risk analysis, and a recall action often hinges precisely on the question of who has purchased a product and what complaints about it are known. Anyone who has already set up that file per article often sees for themselves where the complaints register connects; anyone who still needs to set it up will find an overview of what exactly belongs there in the knowledge base with answers worked out per topic.

What you can concretely do

A workable complaint register does not need to be complicated: a fixed format per report, a fixed location where everyone in your organization reports a complaint, and a brief note about what was done about it. Where things usually go wrong is not the complexity but the habit — the complaint comes in to one employee, is handled, and then disappears from view. A system that prevents that is part of the internal process around product safety and is something different from the product dossier itself; how these two relate to each other within the gpsria.eu offering is described on the page with the components and pricing.

Whether a complaint register is mandatory for your specific situation, and in what form, is ultimately a question that differs per company and is best discussed with a lawyer or the competent supervisory authority. What you can do yourself without waiting for that: start today by recording what is already coming in. Unsure where you stand in the supply chain and what follows from that, first do the free role check or read the frequently asked questions before you proceed with your setup.

This article is general information and not legal advice.