§3.2 Authorised representative

Irrespectively of whether he is established in the EU or not, the manufacturer may appoint an authorised representative in the Union to act on his behalf in carrying out certain tasks. Whether the manufacturer is established in the EU or not, he may appoint an authorised representative in the Union to act on his behalf in carrying out certain tasks required in the applicable Union harmonisation legislation (132). A manufacturer established outside the European Union is not obliged to have an authorised representative (133). For the purposes of Union harmonisation legislation, to be able to act on behalf of the manufacturer, the authorised representative must be established inside the Union. Commercial representatives of the manufacturer (such as authorised distributors or agents), are not to be confused with the authorised representative in the meaning of Union harmonisation legislation. The delegation of tasks from the manufacturer to the authorised representative must be explicit and set out in writing, in particular to define the contents and limits of the representative’s tasks. The tasks that may be delegated to the authorised representative according to the Union harmonisation legislation are of an administrative nature. Thus, the manufacturer may neither delegate the measures necessary to ensure that the manufacturing process assures compliance of the products nor the drawing up of technical documentation, unless otherwise provided for. Further, an authorised representative cannot modify the product on his own initiative in order to bring it into line with the applicable Union harmonisation legislation. Where the manufacturer appoints an authorised representative, the mandate shall at least allow the authorised representative to perform the following tasks: — keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities and cooperate with them at their request, — upon a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product, — cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate. Depending on the conformity assessment procedure or the Union harmonisation act in question, the authorised representative can also, for instance, be appointed to perform tasks, specified in the written mandate, such as: — affix the CE marking (and where relevant other markings) and the notified body’s number to the product, — draw up and sign the EU Declaration of Conformity, — act as the economic operator referred to in Article 4 of Regulation (EU) 2019/1020 to perform the tasks set out in paragraph (3) of that article. The authorised representative who is appointed by a manufacturer may be an importer or a distributor in the meaning of Union harmonisation legislation, in which case he must also to fulfil the obligations of the importer or distributor (134).

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