A foreign company can sell a CE-marked product in France, but the CE logo is not a substitute for a market-entry file. The company must first identify the legislation that applies to the product, determine which entity is the manufacturer, importer, authorised representative or distributor, and make sure that the technical evidence follows the product into the European Union. A French customer, customs officer or market-surveillance authority may look beyond the logo and ask who signed the declaration of conformity, who holds the technical documentation, whose name and address appear on the product, and whether the instructions can be understood in France.

This distinction matters for a founder based in the United Kingdom, the United States, Switzerland, the Middle East or another non-EU jurisdiction. A foreign parent may remain the manufacturer, yet the first EU entity that imports the product can carry its own regulatory duties and may be treated as a producer for civil product-liability purposes. Rebranding can go further: an importer or distributor that markets goods under its own name or trademark can assume the manufacturer’s responsibilities. The practical question is therefore not simply whether a product has a CE mark. It is whether the whole chain can prove lawful placement on the French market and respond quickly when a document, label, batch or safety assessment is challenged.

This product-compliance question should be coordinated with the wider corporate route described in our French company formation legal guide for foreign founders. The two issues are connected, but they are not interchangeable: forming a French company does not by itself make a product compliant, and appointing a French importer does not by itself complete the company’s technical assessment.

I. What must a foreign company establish before placing a CE-marked product on the French market?

A. Is CE marking required, and who is the manufacturer or importer?

The first decision is product classification. CE marking is mandatory only where a European Union harmonisation measure requires it. The French Direction générale des entreprises (DGE, the Directorate-General for Enterprises) states that “L’obligation de marquage CE n’existe que pour les produits couverts par une ou plusieurs directives européennes”. Its official CE-marking guidance also warns that a product outside the relevant legislation must not carry the mark merely to reassure buyers. A CE logo placed on the wrong category can create a compliance problem rather than solve one.

CE means Conformité Européenne, commonly translated as European Conformity. It is a manufacturer’s declaration that the product meets the requirements of the European rules that govern that product at the time it is placed on the EU market. It is not a universal quality label, a French approval, a commercial recommendation or proof that an authority has inspected every unit. Depending on the product, the applicable regime may include machinery, electrical equipment, electromagnetic compatibility, radio equipment, personal protective equipment, toys, medical devices, construction products, pressure equipment or another regulated category. The applicable directive or regulation determines the essential requirements, the conformity-assessment route, the role of a notified body and the documents that must be retained.

A foreign company should therefore begin with a written classification memo. The memo should identify the product’s function, intended users, foreseeable misuse, energy source, components, software, accessories, packaging and sales channel. It should list every potentially applicable EU measure and any French rule that remains applicable because the matter is not fully harmonised. The memo should also record the reason a CE mark is required, or the reason it is not permitted. Where a product is sold to consumers, the general safety framework can apply even if the product is outside a CE regime.

The General Product Safety Regulation, usually called the GPSR, is Regulation (EU) 2023/988 on general product safety. It applies as a safety framework for consumer products and works alongside more specific rules. French law now uses the expression economic operator for the relevant chain. Article L421-1 of the French Consumer Code defines it by referring to “le fabricant, le mandataire, l’importateur, le distributeur” and other persons subject to duties connected with manufacturing or making products available on the market. The current text is available on Légifrance, Article L421-1 of the Consumer Code.

The parties should be mapped by activity rather than by the labels used in a commercial contract:

• The manufacturer designs or manufactures the product, or has it designed or manufactured, and markets it under its name or trademark. A company can be the manufacturer even when production takes place at a factory owned by another business.
• An authorised representative is an EU-established person with a written mandate to perform specified tasks for a manufacturer. The mandate does not automatically transfer every manufacturer obligation.
• An importer is an EU-established person that places a product from outside the EU on the EU market. A French company receiving goods from a United States or United Kingdom manufacturer may be the importer even if another company handles customs paperwork.
• A distributor makes a product available in the supply chain after it has been supplied by a manufacturer, importer or another distributor. A wholesaler and a retailer can both be distributors.
• A fulfilment service provider may store, package, address and dispatch products without owning them. In certain regulatory situations, it can become the EU economic operator that authorities expect to find.

The distinction between a customs representative and an importer is especially important. A customs broker can submit a declaration on behalf of another party without assuming the entire product-compliance role. Conversely, a company that purchases goods, takes title, controls the French launch and appears on the packaging may have importer responsibilities even if a logistics provider files the customs entry. The written contract must match the commercial reality.

For products covered by the legislation listed in Article 4(5) of Regulation (EU) 2019/1020, a product may be placed on the EU market only when an economic operator established in the Union is responsible for defined tasks. The regulation states that a product “may be placed on the market only if there is an economic operator established in the Union”. The official text of Regulation (EU) 2019/1020 identifies the manufacturer established in the Union, the importer where the manufacturer is not established in the Union, an authorised representative with a written mandate, or in defined cases a fulfilment service provider. This is a regulatory presence requirement, not necessarily a requirement to create a French subsidiary.

A non-EU group should identify the EU-established entity before advertising or shipping. If the only proposed contact is the overseas manufacturer, the company should ask whether the product-specific legislation requires a Union operator and whether the foreign entity has appointed an authorised representative with the correct written mandate. If the French buyer is expected to act as importer, that buyer should agree to the role expressly and receive the evidence needed to perform it. Calling the French customer a “reseller” does not remove a role imposed by the supply chain.

Private-label sales create a separate escalation. Article 13 of the GPSR treats a person as a manufacturer where that person places a product on the market under its own name or trademark. Similar provisions appear in sectoral EU measures. An importer that replaces the original brand with its own brand, changes a safety-critical component, changes the intended use or makes a modification that can affect conformity should assume that a manufacturer-level review is required. The correct question is not who paid the factory; it is who presents the product to the market and who controls the features on which conformity depends.

Before the first shipment, the foreign company should have a one-page role chart containing the legal name, address and contact route for each actor. It should state who signs the declaration of conformity, who keeps the technical file, who receives complaints, who can instruct a stop-sale, who reports a dangerous product and who has authority to communicate with French authorities. That chart is a simple way to prevent the common failure in which three companies each believe that another company holds the missing document.

B. Which technical file, declaration, label and French instructions must be ready?

CE compliance is built through a conformity-assessment process, not by ordering a sticker. The manufacturer must select the applicable procedure under the product legislation. Some products can be assessed through internal production controls. Others require testing or assessment by a notified body, meaning an organisation designated by a Member State for specific conformity tasks. A laboratory report can support a file, but a private test certificate does not automatically replace the legally required declaration of conformity or the prescribed assessment procedure.

The declaration of conformity should identify the manufacturer, the product or model, the applicable legislation, the standards or technical specifications used, the notified body where relevant, the signatory and the date. It must remain consistent with the product actually sold. A declaration for an earlier model, a different voltage, an earlier software version or another factory is not a safe substitute. When the applicable law changes, the product changes or the manufacturer’s contact details change, the declaration and the underlying assessment should be reviewed.

The DGE explains in its official CE-marking page that the declaration is prepared by the manufacturer, wherever it is established, or by an authorised representative established in the European Economic Area where the relevant rules permit that route. The same guidance describes the technical file as the evidence used to demonstrate conformity. It generally includes the product description and production process, drawings or design information, risk analysis, calculations, test reports, applicable standards, component information, software information where relevant, labelling, instructions and the declaration. The exact contents depend on the product legislation; an importer should not assume that one generic checklist covers every category.

A useful technical-file index for a foreign company contains at least the following sections:

• Product identity: model, variants, serial or batch system, photographs, intended use and reasonably foreseeable misuse.
• Role and manufacturing information: legal manufacturer, factories, subcontractors, production controls and change-control contacts.
• Legal classification: applicable directives or regulations, national rules, exclusions, harmonised standards and any reasoned decision not to apply a suspected rule.
• Risk evidence: hazard identification, risk assessment, protective measures, residual risks, warnings and the relationship between the assessment and the instructions.
• Testing and assessment: test reports, calculations, certificates, notified-body communications, inspection records and corrective actions.
• Declaration and labelling: signed EU declaration of conformity, CE artwork, model identification, manufacturer details, importer details where required and any notified-body number.
• Market information: sales countries, customer type, online listing, packaging, language versions, complaint route and distribution records.

The importer’s verification should be documentary and physical. Under Article 11 of the GPSR, “Before placing a product on the market, importers shall ensure that the product complies with the general safety requirement”. The importer should obtain the declaration and a meaningful technical-file index before shipment, compare the model number with the goods, check the CE mark and other mandatory marks, review the manufacturer’s identity, verify the instructions and check that the manufacturer can be reached. The importer does not always need to receive the entire confidential technical file before each delivery, but it needs a reliable route to obtain the relevant documentation promptly and must know what it is holding and where it is held.

Article 11 also requires the importer’s name, registered trade name or trademark, postal address and electronic address to appear on the product, its packaging or an accompanying document where the product itself cannot reasonably carry the information. The importer’s additional label must not obscure information required by Union law. A foreign company should approve the final artwork before production, not after goods have arrived in a French warehouse. The address must be one at which the importer can actually receive complaints, authority requests and safety notices.

French language requirements are a frequent point of failure. Instructions and safety information must be provided in a language that consumers and other final users can easily understand, and the product-specific French rules may require French wording on the product, packaging, manual or warnings. For a product made available in France, an English-only manual is not automatically sufficient. The translation should be technically accurate, consistent with the risk assessment and reviewed for warnings, units, limitations, installation steps and emergency instructions. A literal translation that reverses a safety instruction can create a more serious defect than an omitted marketing sentence.

The official Your Europe guidance on product compliance states that an importer must check the conformity-assessment procedure, technical documentation, labels and traceability information, and that instructions and safety information must be in a language easily understood by consumers and final users under the rules of the Member State. The European Commission’s guidance for importers and distributors similarly requires the importer to check that the non-EU manufacturer has taken the steps needed for EU-market access and that the declaration and technical documentation are available on request.

The retention period should be built into the group’s document system. Article 11(6) of the GPSR requires the importer to keep the copy of the technical documentation referred to in Article 9(2) available to market-surveillance authorities for ten years after placing the product on the market. Sectoral CE legislation can contain its own retention period or a point from which the period runs. The company should preserve the signed version, the version supplied with the shipment, the product photographs and the change history. A link to a cloud folder that can later be overwritten is not a robust evidence trail.

Traceability should work in both directions. The company should be able to connect a unit, batch or serial number to the manufacturing lot, shipment, importer, distributor and customer group. It should also be able to identify every recipient of a potentially affected batch. French authorities may ask for the immediate supplier and the immediate customer. The European framework expects the chain to cooperate; a supply agreement should therefore require timely sharing of batch data while respecting personal-data rules.

Online selling does not avoid these obligations. A listing aimed at French consumers should display the required economic-operator information and the relevant product-safety information in a form that is accessible before purchase where the applicable law requires it. A marketplace may request the declaration, photographs of the label, manufacturer contact details and evidence of the EU-established operator. A foreign company should align the online listing, packaging and manual. A product page that says “CE certified” while the declaration says something different is an avoidable inconsistency.

One practical pre-launch gate is a signed release sheet with five decisions: classification complete; assessment route complete; declaration signed; French label and instructions approved; EU operator and evidence-retention route confirmed. The release sheet should identify the precise model and version. If one item is marked “to follow”, the product should remain in a pilot or internal evaluation stage rather than being presented as ready for French commercial sale.

II. What happens if the importer or distributor discovers a compliance problem?

A. Who bears product liability, customer warranty and regulator exposure?

The first response is operational: stop the next placement, preserve evidence, identify the affected models and ask whether the problem concerns a document, a label, a foreseeable use, a batch, a component or an actual safety risk. An importer that has reason to believe that a product is not compliant must not continue placing it on the market until conformity is restored. If the product is dangerous, the importer must inform the manufacturer and ensure that market-surveillance authorities are informed through the Safety Business Gateway under the GPSR. A distributor must also stop making a non-compliant product available and cooperate with corrective measures.

French public guidance makes the chain-wide nature of the duty clear. The Directorate-General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) guidance states that “En tant que professionnel, vous êtes responsable de la sécurité du produit ou du service que vous commercialisez”. DGCCRF is the French administration that investigates consumer protection, competition and fraud matters. The guidance covers manufacturers, representatives, importers and other professionals in the commercial chain. A distributor cannot safely rely on the statement that it did not design the product if its own handling, label, storage or sales presentation contributed to the risk.

Article L422-1 of the French Consumer Code links the French prohibition framework to products that do not satisfy Regulation (EU) 2023/988. Its current text begins: “Les produits ne satisfaisant pas aux exigences du règlement (UE) 2023/988”. The official provision is available on Légifrance, Article L422-1. Depending on the product and the breach, authorities may require withdrawal, corrective action, warnings, destruction, a ban or another measure. The exact consequence depends on the applicable sectoral legislation, the risk and the conduct of the operator.

There is also a specific criminal exposure for failure to implement certain corrective measures. Article L452-5-1 of the Consumer Code provides that failure by a manufacturer or importer to implement measures required by Article 9(8) or Article 11(8) of the GPSR is “puni d’une peine d’emprisonnement de cinq ans et d’une amende de 600 000 euros”, subject to the statutory conditions and any applicable adjustment. The official text is on Légifrance, Article L452-5-1. The provision is not a reason to panic at every paperwork discrepancy; it is a reason to escalate a known safety issue through a documented decision process rather than leaving it unanswered.

Separate from administrative or criminal measures, the foreign business must assess civil product liability. Article 1245 of the French Civil Code states that “Le producteur est responsable du dommage causé par un défaut de son produit”, whether or not the producer has a contract with the injured person. The official provision is available at Légifrance, Article 1245 of the Civil Code. Article 1245-3 defines a defective product as one that does not provide the safety that a person may legitimately expect, taking account of the presentation, reasonably expected use and time of circulation. See Article 1245-3 on Légifrance.

Importers must pay close attention to Article 1245-5. It assimilates to a producer any professional who presents itself as the producer by putting its name or trademark on the product, and any professional who imports a product into the European Community for sale, lease or another form of distribution. The full provision is available at Légifrance, Article 1245-5 of the Civil Code. The wording is old in its reference to the European Community, but the legal issue remains highly relevant to a foreign company’s French distribution model.

The Cour de cassation made the point in a decision concerning parallel importation. In Cass. 1re civ., 4 June 2014, no. 13-13.548, published in the Bulletin, the court held that “l’assimilation d’un importateur à un producteur soit limitée au seul importateur de produits en provenance de pays tiers” was not required by the text. It also treated the professional that placed its own name on the product as assimilated to the producer. The lesson for a foreign group is practical: the importer’s exposure cannot be assessed solely by looking at the factory’s location or by inserting a short disclaimer into the resale agreement.

The claimant still must prove the legally required elements. Article 1245-8 requires proof of the damage, the defect and the causal link between the defect and the damage. The provision is available at Légifrance, Article 1245-8. In Cass. 1re civ., 27 June 2018, no. 17-17.469, the Cour de cassation stated that “la simple implication du produit en cause dans la réalisation du dommage ne suffit pas à établir son défaut”. A product’s involvement in an accident is not by itself proof that the product lacked the safety that could reasonably be expected.

Evidence can nevertheless be built through consistent factual indications. In Cass. 1re civ., 9 December 2020, no. 19-17.724, the court accepted that proof of the defect and causation can be made by “présomptions pourvu qu’elles soient graves, précises et concordantes”. The decision is particularly relevant to an importer because missing batch records, inconsistent incident reports, unexplained product changes and a lost technical file can make a dispute harder to defend. The legal burden is not removed by a CE mark; the mark may be evidence of the manufacturer’s assessment, but it does not prove that every later unit was safe or that every instruction was adequate.

The strict product-liability regime has boundaries that should be analysed rather than assumed. In Cass. com., 26 May 2010, no. 08-18.545, published in the Bulletin, the court recalled that the defective-product regime excludes other ordinary contractual or tort regimes based on the same lack of safety, subject to the statutory exceptions. It described the exceptions as “la responsabilité pour faute et de la garantie des vices cachés”. This means that a contractual claim, a distinct fault or a hidden-defect argument may still matter, but the pleading must identify a legal basis that is genuinely different from the same alleged product-safety defect.

Damage to the product itself is another boundary. In Cass. 1re civ., 14 October 2015, no. 14-13.847, the Cour de cassation stated that “le régime de la responsabilité du fait des produits défectueux ne s’applique pas à la réparation du dommage” where the loss is damage to the defective product itself, absent the statutory damage to a person or another asset. A foreign manufacturer and French importer should therefore separate claims for bodily injury, damage to other property, product replacement, business interruption and the product’s own repair cost when reviewing insurance and contract rights.

Article 1245-6 addresses the position of a supplier where the producer cannot be identified. The professional seller or supplier can be responsible in the same conditions as the producer unless it identifies its own supplier or the producer within three months after the victim’s request is notified. The full rule is available at Légifrance, Article 1245-6. A French distributor should not assume that a distant manufacturer’s absence from the French proceedings will end the matter. It should keep the supply chain identifiable and respond to a claim within the statutory period.

Contractual limitations also have limits. Article 1245-14 prohibits clauses that exclude or limit liability for defective products, while allowing a specific exception for certain damage to business assets used by a professional. The official text is at Légifrance, Article 1245-14. A foreign supplier cannot use an indemnity clause to erase the victim’s mandatory rights. The clause can still allocate the financial burden between the manufacturer and importer, but the allocation will operate as a recourse or indemnity question after the legally responsible party has addressed the victim or authority.

Finally, the limitation periods should be recorded. Article 1245-16 provides a three-year period for an action for compensation under the chapter, running from when the claimant knew or should have known of the damage, the defect and the producer’s identity. The official text is available at Légifrance, Article 1245-16. The ten-year long-stop rule and the rules for interruption, evidence and contractual claims require a separate review. Preserving the technical file for ten years under product-safety rules is not the same thing as guaranteeing that every possible claim has the same limitation period.

B. How should a foreign supplier build the contract, evidence pack and corrective-action plan?

The contract should begin with an accurate allocation of roles. It should say whether the French entity is an importer, distributor, authorised representative, manufacturer for a private-label product or another economic operator. It should identify the products and versions covered, the EU-established contact, the address placed on the label, the person who controls the declaration and the person who can communicate with authorities. If the parties leave this to a generic “seller” definition, the contract may conflict with the actual route by which the goods enter France.

A workable compliance annex should require the foreign manufacturer to deliver, before shipment:

• the signed declaration of conformity and every applicable certificate or notified-body document;
• a current technical-file index and a procedure for providing the underlying documents when a regulator or importer needs them;
• the risk assessment, test reports, production controls, component list and change history appropriate to the product;
• approved photographs of the product, packaging, CE mark, model identification, importer details and warnings;
• the French instructions and safety information, plus the source-language version used for technical review;
• batch, serial-number, shipment and customer records sufficient to trace units in both directions;
• named contacts able to answer a safety or regulator request within a defined number of hours; and
• notice of any design, component, software, factory, supplier, intended-use or legal change before the change reaches the French market.

The annex should also state what happens when a document is missing. The importer should have a contractual right to suspend shipment or payment without being treated as in breach when the legal release conditions are not met. The supplier should reimburse reasonable costs caused by its non-compliance, including testing, translation, storage, investigation, customer communication, withdrawal and recall where legally recoverable. The clause should distinguish between a manufacturer fault, an importer’s own storage or labelling fault, a distributor’s sales conduct and an external event. A blanket indemnity may be difficult to apply if it ignores causation.

Insurance should match the route to market. The foreign manufacturer should provide evidence of product-liability coverage that responds in France and in the other countries in which the goods are sold. The French importer should check whether its own policy covers products placed under its own name, private-label activity, defence costs, withdrawal and recall expenses, and claims involving a component or software update. The policy should be reviewed after a business model change. A distributor that becomes the brand owner may discover that its old reseller policy does not cover the new risk.

The corrective-action protocol should be short enough to use at 7 a.m. on a shipment day. It should name the incident mailbox, the decision owner and the substitute owner. It should require immediate preservation of samples, photographs, complaints, shipment records, customer communications and test data. It should define a stop-sale threshold and a risk-assessment process. It should state when the manufacturer, importer, distributor, marketplace, insurer and counsel are informed. It should identify the route for a regulatory notification, including the Safety Business Gateway where the GPSR requires it.

For a consumer product, the company should decide in advance who prepares the French customer message. It should explain the product, model and batch, the identified risk, the safe action, the refund or repair route and the contact channel. It should avoid a message that says only “the product is under review” when the business already knows that customers must stop using it. The public communication must be consistent with the technical assessment and the regulator’s instructions. A translation review is part of the safety response, not a marketing afterthought.

For online sales, the company should preserve a copy of each French product listing and its dates. Changes to a product page can alter the description of intended use or safety information even when the physical product is unchanged. The compliance file should retain the listing, photographs, customer questions and complaint history. If a marketplace supplies the listing template, the importer should still verify the final display. The EU framework places duties on online marketplaces and economic operators, but the platform’s terms do not remove the importer’s own obligations.

A foreign company should also plan the authority-response route. The person responding to a French authority must be able to provide documents in an understandable format, explain the role chart, identify affected batches and state what corrective action has already been taken. The response should not contain an unverified assertion that the CE mark proves compliance. It should set out the legal classification, the assessment route, the evidence available, the risk decision and the next action. Where confidentiality is important, the company should discuss the scope and format of disclosure with counsel before sending the full technical file, without using confidentiality as a reason to delay a safety response.

A useful closing checklist for a foreign company selling in France is:

1. Classify the product and identify the exact EU and French rules.
2. Record the manufacturer, authorised representative, importer and distributor roles based on the real supply chain.
3. Complete the conformity assessment and sign a product-specific declaration of conformity.
4. Build and version the technical-file index, with a reliable ten-year retention route where the GPSR applies.
5. Approve the CE mark, product identity, manufacturer and importer information, warnings and French instructions.
6. Test the physical unit, packaging and online listing against the approved evidence.
7. Put batch and customer traceability in place before the first commercial shipment.
8. Sign a compliance annex covering changes, audits, access to documents, incident notice, indemnity and insurance.
9. Run a stop-sale and regulator-notification exercise with the manufacturer and French importer.
10. Keep a dated release decision for each model and each material change.

This method is particularly important where the foreign business wants to avoid incorporating a French company at the outset. A French subsidiary is not a universal cure for a missing technical file, and the absence of a subsidiary is not a universal exemption. The legal result depends on the product legislation, the EU-established operator, the import route, the brand displayed to customers, the intended use and the acts performed by each party. Corporate formation, customs, tax and employment advice should be coordinated with product-compliance advice rather than used as a substitute for it.

Conclusion

A foreign company can enter the French market with a CE-marked product, but it should treat the launch as a documented legal process. The CE mark must correspond to the correct product legislation; the declaration, technical file, label and French safety information must correspond to the exact model; and an EU-established operator must be identifiable where the applicable rules require one. An importer can carry independent verification duties and can be assimilated to a producer for civil liability, while a private-label distributor can assume manufacturer responsibilities.

The safest commercial structure combines a role chart, a versioned evidence pack, a French-language release gate, two-way traceability and a corrective-action protocol that can be activated immediately. A contract can allocate costs and require cooperation, but it cannot erase the rights of an injured person or prevent a French authority from addressing the operator that placed the product on the market. Before the first French shipment, a foreign founder should have the classification, documents, label, language review, insurance and response chain reviewed together.

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