Under Article 9 of GPSR, Regulation (EU) 2023/988, the manufacturer of a consumer product must show it is safe before it is sold, and under Article 11 the importer must check that work before the product enters the EU.
A brand that sells under its own name counts as the manufacturer, even when a factory abroad makes the goods. Below is what each role has to do, in the order it comes up, and where to start this week.
GPSR obligations at a glance
This page sums up the duties of the two main roles: the manufacturer and the importer.
The whole regulation, from scope to fines, is covered in What is GPSR?.
| Fact | Detail |
|---|---|
| Law | GPSR, Regulation (EU) 2023/988, Articles 9 to 12 |
| Who it hits | Manufacturers and importers, with lighter checks for distributors |
| From when | 13 December 2024, for every product placed on the market since |
These duties apply to consumer products that no more specific EU safety law covers, as the GPSR text on EUR-Lex sets out in Article 2. Products under CE-marking laws follow those laws instead, as the FAQ below explains.
Five duties for a manufacturer in order
Article 13(1) treats anyone selling a product under their own name or trademark as the manufacturer. That role carries the heaviest duties, in this order.
Step 1. Design the product to be safe
Article 5 sets the one rule behind everything else: only safe products may be sold. Article 9(1) makes the manufacturer responsible for designing and making the product to meet it.
For anything made in series, Article 9(4) adds procedures that keep every later batch as safe as the first.
Step 2. Write the technical documentation
Before the product goes on sale, Article 9(2) asks for an internal risk analysis and a technical file. At a minimum, the file holds a general description of the product and the features that matter for its safety.
Where the risks call for it, the file also covers:
- The risks and the fixes chosen to remove or reduce them
- Test reports, from your own tests or from a lab on your behalf
- The standards applied, and which parts of them were used
Article 9(3) says to keep the file up to date and ready for the market surveillance authorities for 10 years after the product was placed on the market.
Step 3. Put your details on the product
Article 9(5) asks for a type, batch or serial number that consumers can easily see and read. Article 9(6) adds your name, your registered trade name or trademark, and a postal and an electronic address.
These go on the product, or on the packaging or an accompanying document when that is not possible.
Step 4. Add instructions in the right language
Article 9(7) asks for clear instructions and safety information in a language consumers can easily understand, as set by each country where the product is sold. A product that is safe to use without instructions is exempt from this step.
Step 5. Handle complaints and dangerous products
Article 9(11) asks for a public channel for complaints, such as a phone number, an email address or a page on your website. Article 9(12) then asks you to look into each safety complaint and keep a register of complaints, recalls and corrective measures.
When a product turns out to be dangerous, Article 9(8) asks you to act at once on three fronts:
- Fix it, through a withdrawal or recall where needed
- Tell consumers what the risk is
- Tell the authorities through the Safety Business Gateway, the European Commission's web portal for these reports
What an importer has to do under GPSR
An importer is the EU company that brings a product from outside the EU onto the EU market (Article 3(10)). Article 11 makes it the manufacturer's checkpoint.
The importer's five checks, in order
- Check before selling. The product must be safe, and the manufacturer must have done the technical file, the product number and the contact details. If not, the importer may not sell it until it is fixed (Article 11(1) and (2)).
- Add its own details. Its name and addresses go on the product too, and any extra label must not cover what the manufacturer printed (Article 11(3)).
- Keep the product safe in its hands. Storage and transport must not damage the product or its labels (Article 11(5)).
- Keep a copy of the file. The technical documentation stays available for 10 years (Article 11(6)).
- Act on danger. It tells the manufacturer and makes sure the product is fixed, consumers are told and the authorities are informed. If the manufacturer does nothing, the importer acts itself (Article 11(8)).
For a seller outside the EU, the importer is often also the company that answers to the authorities for the product. Its tasks come from Article 4 of the Market Surveillance Regulation on EUR-Lex, and the role is explained in What is a GPSR responsible person?.
Distributors carry lighter checks under Article 12. They verify the details and instructions are on the product, and stop selling one that falls short.
Where to start this week
Pick your best-selling product and look for its technical file. If there is no risk analysis and no record of the tests behind it, start there, because Article 11(1) means your importer must check that file before selling your goods.
The same product's packaging, and any electronics or batteries inside it, also carry EPR duties in each EU country where it is sold, as the guide to EPR registration in Europe explains. Repax does not write GPSR technical files or act for you towards the authorities on product safety.
Not sure if you are registered in every country you sell in?
We will run a demo on a representative product and discuss your specific EPR mix.
- How many EU markets do you sell into?
- Do you import from outside the EU?
For the whole regulation, from the products it covers to fines and enforcement, read What is GPSR?.
Frequently asked questions about GPSR obligations
Below are the four questions sellers ask most about what GPSR asks of manufacturers and importers.
Does GPSR apply to products with a CE marking?
Only in part. Under Article 2(1), the manufacturer and importer duties in Articles 9 to 18 do not apply to products covered by EU harmonisation laws, such as toys or electronics. The GPSR rules on online sales and accidents still apply to them.
How long must GPSR technical documentation be kept?
For 10 years after the product was placed on the market. Article 9(3) puts that duty on the manufacturer, and Article 11(6) makes the importer keep a copy for the same period, ready to hand to the market surveillance authorities on request.
Who reports a dangerous product under GPSR?
The manufacturer informs the authorities through the Safety Business Gateway under Article 9(8). The importer must make sure that happens under Article 11(8), and a distributor must make sure the authorities are informed under Article 12(4).
Can an importer sell a product without the manufacturer's documents?
No. Article 11(2) says an importer that believes the manufacturer has not done the technical file, the product number or the contact details must not place the product on the market until those gaps are fixed.
