There is no fixed amount for a complaints register, and anyone who promises otherwise is selling you false certainty. What does determine the costs is a combination of factors: how many products and product categories you stock, how many EU countries you sell in, how many complaints and notifications you receive, and whether you keep track of them manually or via a system. With a handful of products and few complaints, a simple register is often sufficient; with hundreds of SKUs across multiple countries, the time investment quickly adds up.
The regulation requires undertakings that qualify as manufacturers to record complaints about the safety of their products and assess whether they warrant further action. This is therefore not simply a matter of maintaining an Excel file, but of a process that works consistently: who receives a complaint, how it is recorded, and how it is determined whether something is an incident or a pattern. Most of the cost lies in that last step, not in the register itself.
What a complaints register must actually contain
A complaints register is more than a list of customer remarks. Supervisory authorities look at whether an undertaking can demonstrate when a complaint was received, what the nature of the complaint was, which product and which batch or type it concerned, and what assessment was made about follow-up steps. Without that link to type and batch numbers, a register is difficult to use when it really matters.
That link is precisely where the time investment lies. A webshop with ten products can maintain this manually without much effort. An importer with hundreds of articles across multiple categories, spread across several EU countries, soon needs a system that automatically links complaints to the correct product and file.
What determines the scope of costs
Four factors play the largest role. First, the number of products and product lines: the more items, the more separate files and thus more management. Second, the number of countries in which you sell, because complaints from different member states sometimes arrive in different languages yet must be recorded centrally. Third, the complaint volume itself: an undertaking with little customer contact about safety needs a lighter process than one that receives notifications daily. Fourth, the choice between your own manually maintained register and a system that standardizes the process.
That last choice often determines the largest part of the costs. Maintaining it manually costs no money on software, but it does cost time, and that time increases as the number of products grows. A system does involve a fixed contribution, but saves time because complaints are automatically linked to the correct product file and associated risk analysis. What is most efficient for your situation depends on the size of your range; in a few questions you can see which role and obligations apply to you provides a first indication of that.
The relationship with the rest of the file
A complaints register does not stand alone. It must link together with the risk analysis and technical documentation for each product, because a complaint only becomes meaningful if it can be traced back to a specific article and a risk assessment. Components that are maintained separately lead in practice to duplicated work: the same information is then entered twice, in two different systems, with the risk that they diverge.
Whoever links the complaints register to the product file from the start saves time in the long run, even though the initial setup may feel more demanding. More about how the file, risk analysis and complaints register interrelate is detailed in the knowledge base with explanations by topic.
Keep your own records or get support
Whether your own register is sufficient or whether support is needed depends heavily on the scale of your business. A small installation company selling a handful of products under its own brand can often get by with a simple template. An online retailer with a broad and changing product range, spread across multiple categories and countries, will sooner discover that manual record-keeping becomes error-prone as volume grows.
The actual costs of a system that structures this for you depend on the number of products and the desired functionality; a current overview of this is on the page with current pricing. How that information is compiled and what the estimates are based on, you can read on the page explaining where the information on the platform comes from.
What approach is most efficient for your business remains an assessment you make yourself or together with an adviser. A free first step with no obligation is the complimentary role check, which in a few questions indicates which obligations apply to your situation, without needing an account for that.