§3.2 Economic operator also assuming the role of the responsible person

A product covered by the GPSR cannot be placed on the market without an economic operator established in the EU, the ‘responsible person’ , who is responsible for performing the tasks set out in Article 4(3) of Regulation (EU) 2019/1020 and in Article 16 of the GPSR in respect to that product. Who is the responsible person? The responsible person is any of the following: (a) a manufacturer established in the EU; (b) an importer, if the manufacturer is not established in the EU; (c) an authorised representative who has a written mandate from the manufacturer that designates it to perform the tasks of the responsible person on the manufacturer's behalf; (d) a fulfilment service provider established in the EU with respect to the products it handles, if no other economic operator as mentioned in points (a), (b) and (c) is established in the EU. What are your tasks as responsible person? As a responsible person, you have additional obligations on top of those you already have as an economic operator under the different categories explained above. You have the following additional tasks: (a) Verifying that the technical documentation has been drawn up and ensuring that the technical documentation can be made available to the market surveillance authorities upon request. (b) Further to a reasoned request from a market surveillance authority, providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which that authority can easily understand. (c) Informing the market surveillance authorities if you have reason to believe that a product presents a risk. (d) Cooperating with the market surveillance authorities (including following a reasoned request): i. to make sure that immediate, necessary and corrective action is taken to remedy any case of non-compliance with the requirements set out in the GPSR; or ii. if that is not possible, to mitigate the risks presented by that product, when required to do so by the market surveillance authorities or on your own initiative, if you consider or have reason to believe that the product in question presents a risk. (e) Where appropriate with regard to the possible risks related to a product, regularly checking: i. that the product complies with the technical documentation drawn up by the manufacturer. This means that the possible risk(s) the product might pose have been eliminated or mitigated by the manufacturer as described in the technical documentation, e.g., by applying relevant European standards or other means; and ii. that the product complies with the following requirements: — That the product bears a type, batch or serial number or other element that makes it possible to identify the product, and which consumers can easily see and read. Alternatively, if the size or nature of the product does not allow this, the required information must be provided on the packaging or in a document accompanying the product. — That the manufacturer has indicated its name, its registered trade name or registered trademark, its postal and electronic address and, where different, the postal or electronic address of the single contact point where it can be contacted. That information should be placed on the product or, if that is not possible, on its packaging or in a document accompanying the product. — That the product is accompanied by clear instructions and safety information in a language which consumers can easily see and read as determined by the Member State in which the product is made available on the market. That requirement does not apply if the product can be used safely and as intended by the manufacturer without such instructions and safety information. You should, upon request by the market surveillance authorities, provide documented evidence of the checks performed. (f) Ensuring your name, registered trade name or registered trademark, and contact details (including the postal and electronic address) are indicated on the product or on its packaging, the parcel or an accompanying document; and What does “electronic address” mean? An electronic address can be an e-mail address or dedicated section of your website that enables consumers to contact you directly. A website as such is not sufficient if it does not allow direct communication with you. (g) If you have knowledge of an accident caused by a product that you are responsible for, ensuring that this accident is notified through the Safety Business Gateway without undue delay from the moment you know about the accident, to the competent authorities of the Member State where the accident has occurred. The notification must include the type and identification number of the product as well as the circumstances of the accident, if known. You should notify any other relevant information to the competent authorities upon request. For further specifications on the roles of responsible persons, please see the Commission “ Guidelines for economic operators and market surveillance authorities on the practical implementation of Article 4 of Regulation (EU) 2019/1020 on market surveillance and compliance of products” (25). Check list for the responsible person in the EU ✓ Verify that the technical documentation has been drawn up by the manufacturer and make sure you can provide it to authorities upon request. ✓ Ensure your identification and contact details are indicated on/with the product. ✓ Regularly check that the product complies with the technical documentation: this means that the possible risk(s) the product might pose have been well eliminated or mitigated by the manufacturer as described in the technical documentation. ✓ Regularly check that the product identification details, the manufacturer’s and importer’s identification and contact details are correctly affixed to the product or its packaging and accompanied by instructions and safety information if needed. ✓ Cooperate with market surveillance authorities and provide them all information and documentation, when requested. ✓ If you become aware that a product presents a safety risk: — inform national authorities via the Safety Business Gateway; — inform the manufacturer; — make sure that corrective action is immediately taken. If the manufacturer hasn’t done so, do it yourself! ✓ Report product-related accidents you become aware of via the Safety Business Gateway. ✓ Fulfil the obligations that you have as a manufacturer, importer, authorised representative or fulfilment service provider. For more details, refer to the section 3.2. on the obligations of the responsible person in the EU.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07