GPSR post-market obligations: the duties after launch
10 min read
GPSR post-market obligations for makers outside the EU: complaints, accidents, recalls, file updates and Responsible Person checks, with a yearly plan.
Your product is on sale in the EU: the risk analysis is done, the label names your Responsible Person, the listings are complete. Under the General Product Safety Regulation (GPSR), most post-market obligations are tied to events: a complaint, an accident, a supplier change, a letter from an authority. Here is what triggers each duty, who acts when your company is outside the EU, and a yearly rhythm to keep it manageable.
What changes once your product is on the market
Placing on the market means the first time a product is made available in the EU (Article 3(7) of Regulation (EU) 2023/988 (opens in a new tab), the GPSR, applicable since 13 December 2024).
Two duties run in the background: an up-to-date technical file (Article 9(3)) and procedures that keep series production safe (Article 9(4)), backed by internal processes such as quality controls and complaint handling (Article 14; Commission GPSR guidelines C/2025/6233 (opens in a new tab), point 3.1.1).
GPSR post-market obligations by trigger
The last column shows who acts when the manufacturer is outside the EU. Reports go through the Safety Business Gateway, the Commission's online portal for businesses.
| Duty | Legal basis | Trigger | Who acts |
|---|---|---|---|
| Keep the technical documentation current and available for 10 years; keep series production safe | Art. 9(3), (4) | Change of design, component or supplier; new risk information | Manufacturer; the Responsible Person makes sure the file can be provided (Art. 4(3)(a) Regulation (EU) 2019/1020) |
| Public complaints channel; investigate safety complaints; register of complaints, recalls and corrective measures | Art. 9(11) to (13) | Permanent; complaint alleging a dangerous product or information on an accident | Manufacturer; an importer checks the channel and investigates too (Art. 11(9), (10)) |
| Take corrective measures, inform consumers and report through the Safety Business Gateway | Art. 9(8) | Reason to believe a product is dangerous | Manufacturer; the Responsible Person informs authorities and makes sure action is taken (Art. 4(3)(c), (d) Regulation (EU) 2019/1020) |
| Notify accidents | Art. 20 | Death or serious adverse effects on a person's health and safety | Manufacturer; the Responsible Person that knows of it ensures it is done (Art. 20(4)) |
| Check product and labeling against the file, with documented evidence | Art. 16(2) | Where appropriate with regard to the risks | Responsible Person |
| Answer authorities: risks, complaints, accidents, measures (10 years); suppliers and business customers (6 years) | Art. 15 | Request from a market surveillance authority | Every economic operator |
| Notify affected consumers directly, publish a recall notice where not all can be reached, offer remedies | Art. 35 to 37 | Product safety recall or safety warning | The economic operator responsible for the recall |
Reporting routes and recall rules step by step: Safety Business Gateway and product recalls.
When a safety complaint comes in: six steps
- Log it. Record product, batch and what happened in your register, with only the personal data the investigation needs (Article 9(12), (13)).
- Check for an accident. If someone died or suffered serious harm to health and safety, make sure it is notified through the Safety Business Gateway without undue delay (Article 20(1), (2)).
- Find the cause. Has a part, supplier or process changed since the file was written (Article 9(4))?
- Decide whether the product is dangerous. If you have reason to believe it is, act immediately: corrective measures, consumer information, a report to the authorities wherever it was sold (Article 9(8)).
- Update the file. Add the new risk and the measure to the risk analysis (Article 9(3)); see how to keep the risk analysis current.
- Close the loop. Tell your Responsible Person, importers, distributors and marketplaces what you found (Article 9(10)) and record the outcome.
What the Responsible Person checks, and what the GPSR does not require
Beyond its tasks under Article 4(3) of Regulation (EU) 2019/1020 (opens in a new tab), the Responsible Person must, where the possible risks make it appropriate, regularly check that the product matches the technical documentation and carries the identification, manufacturer details and instructions of Article 9(5) to (7), and show documented evidence of these checks on request (Article 16(2) GPSR). Neither the GPSR nor the guidelines (point 3.2) set a frequency or a sampling method.
We recommend planning the checks by risk. For a stable, low-risk product, comparing each new batch's label and instructions with the file can be enough; a children's product or one with complaints needs more. Agree rhythm and evidence in writing.
When the manufacturer does not act: guidance and the mandate
Article 4(3)(d) of Regulation (EU) 2019/1020 requires the Responsible Person to make sure that corrective action is taken. Two Commission guidance documents read this differently:
- Blue Guide 2022, section 3.6: the operator need not take corrective action itself unless sector law obliges it, but must ensure it is taken, for example by asking the manufacturer and verifying that it acted.
- GPSR guidelines, checklist in point 3.2: "If the manufacturer hasn't done so, do it yourself!"
Neither document is binding law. An Authorized Representative performs the tasks in its written mandate, which must at least allow it to report action taken against the risks through the Safety Business Gateway where the manufacturer has not (Article 10(2) GPSR). Either way, the manufacturer keeps its responsibility for the product (Blue Guide 2022, sections 3.1 and 3.6).
If the mandate ends without a successor, Article 16(1) GPSR bars further placing on the market; see what customs and authorities can then do.
CE-marked products: which of these duties still apply
Many consumer products, such as lamps, chargers or toys, also carry CE marking. For them, Chapter III, Section 1 of the GPSR (Articles 9 to 18) does not apply, and the general safety requirement covers only risks the sector law leaves open (Article 2(1)). Accident notification (Article 20), online listing details (Article 19) and the recall rules (Articles 35 to 37) still apply (C/2025/6233, point 2.2).
| Duty | Covered only by the GPSR | CE-marked, for example under the Low Voltage Directive |
|---|---|---|
| Complaints and sample testing | Investigate safety complaints, keep a register (Art. 9(12) GPSR); no sample testing | When deemed appropriate with regard to the risks: sample testing, investigation, a register if necessary (Art. 6(4) Directive 2014/35/EU) |
| Tasks of the EU economic operator | Art. 4(3) Regulation (EU) 2019/1020 and Art. 16(2) GPSR | Art. 4(3) Regulation (EU) 2019/1020 only |
A yearly calendar for post-market compliance
The GPSR sets triggers, not dates. Beyond handling complaints and incidents as they arise, this is the rhythm we recommend; adapt it to your products' risks.
| When | What | Legal basis |
|---|---|---|
| Each new batch or supplier | Check type or batch number, manufacturer and Responsible Person details, instructions and warnings in each market's language | Art. 9(4) to (7), Art. 16(2), (3) |
| Monthly | Review open complaints; delete personal data no longer needed | Art. 9(12), (13) |
| At the agreed rhythm | Documented check by the Responsible Person, scaled to the risk | Art. 16(2) |
| Twice a year | Check the Official Journal for new or revised standards; update risk analysis and file | Art. 7(1), Art. 9(3) |
| Once a year | Review mandate, addresses on labels and listings, supplier and business customer lists, recall readiness | Art. 15(3), (5), Art. 16(3), Art. 19, Art. 35, Art. 36 |
For the recall notice, prepare the Commission's template (Implementing Regulation (EU) 2024/1435) before you need it.
Example: a U.S. bunk bed brand, four months after launch
A U.S. brand sells bunk beds to consumers in Germany and France through its own online shop. Furniture has no CE legislation of its own, so the GPSR applies fully (C/2025/6233, point 2.2); an Authorized Representative is the Responsible Person.
Two customers report that a guard rail bracket works loose; nobody is hurt. The brand logs both complaints and finds that its factory switched to shorter screws. It restores the original screw, updates its risk analysis and file and informs the Responsible Person (Article 9(3), (4), (10), (12)).
A loose rail on a raised bed can cause falls, so the brand treats beds already sold as dangerous. It reports to both countries through the Safety Business Gateway (Article 9(8)) and emails every buyer a recall notice headed "Product safety recall" in German and French (Articles 35(1), 36). Buyers choose a refund of the price paid or a free repair kit with instructions that owners can fit easily and safely (Article 37(2), (3)).
When the French authority later asks for complaints and corrective measures, the register already holds the answer (Article 15(2)).
Common mistakes after launch
- Waiting for an injury. The duty to act starts when you have reason to believe a product is dangerous (Article 9(8)), not with the first accident.
- Softening the recall. A recall notice may not call the recall "voluntary" or "precautionary" or say that no accidents were reported (Article 36(2)(c)).
- Keeping complaint data forever. Personal data in the register may be kept only as long as the investigation needs, five years at most (Article 9(13)).
Conclusion: settle the routines before the first complaint
After launch, the GPSR asks for routines: a complaints channel someone answers, a register, a technical file that follows every change, and a clear line on who reports and who recalls. Build them into your market entry plan; your EU distributor may ask about them.
As your GPSR Responsible Person, Representa carries out the Responsible Person's tasks within the agreed scope and mandate; you remain the manufacturer. Compliance consulting helps you plan these routines; for requests from authorities, see market surveillance.
Frequently asked questions
Does the GPSR require sample testing of products already on the market?
No. The GPSR requires the Responsible Person to regularly check products against the technical documentation and labeling rules where the risks justify it, and to document these checks (Article 16(2)). Sample testing of marketed products is a duty under some CE sector laws where the risks call for it, for example Article 6(4) of Directive 2014/35/EU.
How long must I keep records of complaints and accidents?
You must be able to present information on risks, complaints, known accidents and corrective measures for 10 years, and which businesses supplied you and which you supplied for six years (Article 15(4), (5) GPSR). Personal data in the complaints register must be deleted at the latest five years after entry (Article 9(13)).
Who notifies an accident if my company is outside the EU?
As manufacturer, you must ensure that the accident is notified through the Safety Business Gateway (Article 20(1) GPSR). Your Responsible Person in the EU, once it knows of the accident, must also ensure that the notification is made (Article 20(4)). Agree in writing who submits, so the report is neither missed nor duplicated.
Does the GPSR set a date for a yearly review?
No. The GPSR ties post-market duties to triggers such as complaints, accidents, changes to the product and requests from authorities. A fixed yearly review is good practice, not a legal deadline.
Do the same post-market duties apply in the UK?
In Northern Ireland, the GPSR applies under the Windsor Framework. In Great Britain, the General Product Safety Regulations 2005 still applied on 5 October 2026: regulation 7(4) names sample testing of marketed products and a complaints register where reasonable, and regulation 9 requires producers and distributors to notify an enforcement authority of unsafe products.
