The GPSR assigns different safety, documentation, traceability, and escalation duties to manufacturers, authorised representatives, importers, distributors, online sellers, and the EU responsible person.
Use this page to separate the role duties, build the product-safety file, and decide when corrective action, accident reporting, or recall communications must be escalated.
Structured answer sets in this page tree.
Cited legal and guidance references.
GPSR economic-operator work starts with the product and the supply-chain role. A manufacturer owns design safety, risk analysis, technical documentation, consumer channels, complaint records, and dangerous-product escalation. Importers check manufacturer duties before EU placement and preserve technical documentation. Distributors verify visible product, operator, instruction, and safety-information requirements before making the product available. Products covered by the GPSR also need an economic operator established in the Union for the responsible-person tasks referenced by Article 16.
Manufacturers should treat Article 9 as the main release gate: confirm the product has been designed and manufactured to meet the general safety requirement, complete an internal risk analysis, draw up technical documentation, keep that documentation current for 10 years after placing the product on the market, and apply serial-production controls.
Importers should not place a product on the EU market until they have checked the general safety requirement and the manufacturer duties for technical documentation, product identification, and manufacturer contact details. Distributors have a narrower gate: before making a product available, they verify required manufacturer and importer identifiers, instructions, safety information, and storage or transport conditions.
An authorised representative needs a written mandate and must at least be able to provide documentation to authorities, warn the manufacturer when it considers a product dangerous, notify authorities through the Safety Business Gateway when required, and cooperate on risk-elimination actions.
The release file should connect product identity, operator identity, and risk evidence. For the manufacturer, technical documentation needs at least a general product description and essential characteristics relevant to safety; where risks make it appropriate, it should also include risk analysis, mitigations, test-report outcomes, and the standards or other safety elements applied.
GPSR traceability is not just a label exercise. Article 15 lets authorities ask economic operators for a risk description, related complaints, known accidents, corrective measures, and supply-chain traceability information. Operators must be able to present risk and corrective-action information for 10 years and upstream/downstream traceability information for six years.
Article 16 adds the EU responsible-person control: a covered product cannot be placed on the Union market unless an economic operator established in the Union is responsible for the referenced Regulation (EU) 2019/1020 tasks. That operator's name, trade name or trademark, postal address, and electronic address must appear on the product, packaging, parcel, or accompanying document.
When a manufacturer has reason to believe a product it placed on the market is dangerous, Article 9 requires immediate corrective measures, consumer information under the recall or safety-warning rules, and notification through the Safety Business Gateway to the affected Member State authorities. Importers and distributors have parallel escalation duties and must ensure corrective measures such as withdrawal or recall happen when appropriate.
Accidents have a separate trigger. A manufacturer must notify, through the Safety Business Gateway and without undue delay from the moment it knows of the accident, occurrences associated with product use that resulted in death or serious adverse effects on health and safety. Importers and distributors that learn of such an accident must inform the manufacturer without undue delay; if the manufacturer is outside the Union, the Article 16 responsible person must ensure notification is made.
For recalls, separate the product-safety decision from the consumer notice. The corrective-action record should state whether the action is withdrawal, recall, warning, destruction, repair, replacement, refund, or another measure. The recall notice then needs product identification, the hazard and why the product is dangerous, immediate consumer actions, available remedies, and contact details.
Map manufacturer, importer, distributor, responsible-person, marketplace, traceability, corrective-action, accident, and recall duties into records your product, legal, quality, support, and operations teams can reuse.
"corrective measures taken or envisaged"
"Product safety recall"
"manufacturers, authorised representatives, distributors and importers"
"report dangerous products and accidents"
"market surveillance and compliance of products"
"internal processes for product safety"