EU GPSR Requirements

Apply the GPSR to products intended for consumers, or likely to be used by consumers under reasonably foreseeable conditions, when they are placed or made available on the EU market. The scope includes new, used, repaired, and reconditioned products unless they are supplied for repair or reconditioning before use and are clearly marked that way.

If another EU law contains specific safety requirements for the product, use that law for the risks it covers and apply the GPSR only to uncovered aspects and risks. For products subject to Union harmonisation legislation, also apply the current Article 2 chapter exclusions: Chapter II is displaced for covered risks, while Chapter IIa, Chapter III Section 1, and Chapters V, VII, and IX to XI do not apply. Chapter IIa's Articles 8b and 8c apply only when all Article 8a conditions are met, including a Commission implementing act under Article 28 of Regulation (EU) 2024/2747, designation of the products as crisis-relevant goods, and activation of internal market emergency mode under Article 18 of that Regulation. Distance-sales, accident, marketplace, Safety Gate, recall, and remedy provisions can remain relevant according to their terms and the same-objective test.

Distinguish placing from making available in the date and role analysis. Placing on the market is the first supply of the individual product on the Union market; making available is any supply for distribution, consumption, or use in a commercial activity, whether paid or free. A later distributor sale can therefore be making available without being a new placement.

Before placing a product on the market, the manufacturer must carry out an internal risk analysis and draw up technical documentation. The minimum file contains a general product description and its essential safety characteristics. Where appropriate for the possible risks, it must also contain risk analysis, mitigation choices, test-report outcomes, and the standards or other safety elements applied.

The safety assessment should cover how the product is designed, composed, packaged, labelled, installed, used, maintained, combined with other products, and presented to consumers. For connected or smart products, the GPSR assessment can also need cybersecurity, interconnection, learning, or predictive-functionality considerations where those features affect safety.

Reopen the safety conclusion when a physical or digital modification affects safety, a supplier or component changes, new test or complaint evidence appears, an accident occurs, a relevant standard changes, or an authority or Safety Gate alert identifies a comparable hazard. Record the changed facts, the reassessment, any updated warning or technical document, and the release or corrective-action decision.

Map the product's operator chain before release. Where GPSR Chapter III, Section 1 applies, manufacturers own product design and manufacture against the general safety requirement, technical documentation, series-production controls, product identifiers, manufacturer contact details, instructions, consumer complaint channels, complaint investigation, and dangerous-product corrective action.

Where GPSR Chapter III, Section 1 applies, importers check that the product and manufacturer file satisfy the GPSR before placing the product on the market, add importer contact details, preserve required technical documentation, control storage and transport risks, investigate complaints or accidents they receive, and trigger Safety Business Gateway reporting when a dangerous product is identified. Distributors verify visible manufacturer, importer, identifier, instruction, and safety-information requirements before making the product available.

Where GPSR Article 16 applies, a product cannot be placed on the EU market unless an economic operator established in the Union is responsible for the product. For imported or non-EU manufacturer routes, this responsible-person check is a release blocker because market surveillance authorities need an EU interlocutor for product-safety evidence and action.

Traceability has two layers. The ordinary layer identifies the product, manufacturer, importer where applicable, responsible person where required, and supply-chain counterparties. A stricter product-specific traceability system can be added by delegated act for products or categories likely to present a serious consumer health and safety risk.

For economic operators selling online or by other distance-sales channels, the product offer must visibly provide the manufacturer name or trade mark and postal and electronic address, the EU responsible person details where the manufacturer is outside the Union, product identification including a picture and type or other identifier, and applicable warnings or safety information in the consumer-facing language required by the Member State.

Online marketplaces have additional system duties. They must register in the Safety Gate Portal, designate product-safety contact points for authorities and consumers, maintain internal product-safety processes, enable traders to provide required product-safety listing data, process product-safety notices within the GPSR timeframe, act on authority orders, cooperate on recalls, and use Safety Gate information for product-safety controls.

The GPSR separates accident notification from dangerous-product corrective-action reporting, but both run through the Safety Business Gateway for businesses. Accident reporting covers occurrences associated with the product's use that caused death or serious adverse effects on health and safety, including injuries, bodily damage, illnesses, and chronic health effects.

When a manufacturer, importer, distributor, authorised representative, responsible person, or online marketplace has GPSR knowledge or reason to believe that a product is dangerous, the record should show who assessed the risk, which Member States are affected, which corrective measures were taken or planned, what consumers were told, and what was submitted through the Safety Business Gateway.

Corrective action should be selected by risk and status of distribution: bring the product into conformity, withdraw it from the supply chain, recall it from consumers, warn consumers, or combine measures. If consumers can be identified, they must be notified directly and without undue delay for recalls and safety warnings; if not all affected consumers can be contacted, a clear and visible notice must be disseminated through appropriate channels.

Written product safety recall information must take the form of a recall notice. The notice needs the mandatory GPSR elements: the words Product safety recall, product identification, hazard, immediate consumer action, remedies, contact route, and encouragement to share the recall where appropriate. Recall remedies must be effective, cost-free, and timely.

A GPSR evidence pack should let a reviewer reconstruct the product, role, market route, safety assessment, listing state, operator chain, incident handling, and corrective action without relying on project memory. It should be maintained as a living release and post-market record, because complaints, accidents, supplier changes, software changes, packaging changes, and authority orders can all reopen the safety conclusion.

The evidence should be article-mapped rather than generic. A scope memo supports Articles 2 and 4, the risk file supports Articles 5 to 9, operator matrices support Articles 9 to 16, listing screenshots support Article 19, marketplace process records support Article 22, accident and dangerous-product submissions support Articles 20 and 27, and recall materials support Articles 35 to 37.