EU Authorized Representative of a non-EU Manufacturer Is Liable for IP Infringement

The European Authorized Representative for a medical device is liable for infringement of IP rights together with the non-EU manufacturer, as the EAR provides an essential contribution to the marketing of the infringing product in a European country.

The case and the first-instance interlocutory decision

The case in question originates from a dispute regarding the infringement of an Italian national 3D trademark registration covering the shape of the wearable unit (OBU) of a device for Continuous Glucose Monitoring ("CGM"). The CGM in question is owned by a leading multinational company in the healthcare sector, and is one of the most well-known products in its market sector globally.

The trademark owner identified a CGM device on the Italian market that infringed its 3D trademark, which was produced in China by a Chinese company. The Chinese manufacturer designated a Belgian company as the European Authorized Representative, as required by Article 11 of EU Regulation No. 2017/745 on medical devices ("the Regulation"), which provides that “the manufacturer of a device that does not have a registered place of business in one Member State may place the device on the market of the Union only if it designates a sole authorized representative”.

The Belgian company designated as the authorized representative for this CGM device was also (i) registered as the sole authorized representative of the product manufacturer on the EUDAMED database (the European Database on Medical Devices), pursuant to Articles 30 and 31 of the Regulation, which provide that "manufacturers, authorized representatives and importers shall register, under their responsibility, in the aforementioned electronic system [...] before placing a device other than a custom-made device on the market"; and (ii) registered in the Italian national medical devices database at the Ministry of Health pursuant to Articles 12, par. 3, and 14 of Italian Legislative Decree 137/2022.

In July 2024, the trademark owner filed an application for preliminary injunction before the Court of Rome against both the Chinese manufacturer and its EU representative for trademark infringement and unfair competition.

During the proceedings, the trademark owner waived its claims against the Chinese company, due to the practical impossibility to serving the application in China within the timeframe necessary to obtain urgent relief. The PI action thus proceeded only against the EU representative, on the basis of its essential role for the entry of the product into the EU market, and thus in Italy.

In the first instance proceedings, the Court of Rome rejected the application against the European representative, arguing that the EU representative's joint and several liability for the infringement of the applicant’s 3D trademark could not be based on its mere role as the manufacturer’s authorized representative, and that there was no evidence of the representative's direct participation in the manufacture or marketing of the disputed product within the EU.

This decision appeared to be in error, because the EU representative has an effective and essential role in the infringement, since it renders the marketing of the medical device in the EU, and specifically in Italy, possible for the non-EU based manufacturer.

Appeal and the final decision of the Court of Rome

In February 2025, the trademark holder appealed the first instance decision of the Court of Rome, arguing that the EU representative is liable for infringement together with the manufacturer and, as a result, can be subject to a preliminary injunction. The trademark holder argued that:

1. The choice and appointment of an EU representative is an essential condition for the non-EU manufacturer to be able to place the medical device on the EU market, and therefore the EU representative has a "key role" in the marketing chain of the infringed device.
   
   
2. Article 11, paragraph 3, of the Regulation specifies that "The mandate shall require, and the manufacturer shall permit, the authorised representative to perform at least the following tasks in relation to the devices covered by the mandate (...)”, thus demonstrating that the duties of the representative listed in Article 11, par. 3, of the Regulation are only minimum obligations ("…at least the following tasks…"), with the result that the representative should also perform guarantee functions related to compliance with all European and national rules, including those concerning IP rights.
   The Regulation does not, therefore, exclude the possibility that the European Authorised Representative designated by a non-EU manufacturer shall carry out other guarantee functions towards the manufacturer and its products, not only in case of defective products but also regarding other violations of European and national regulations.
   
   
3. According to the Italian national law, any subject that has participated in the infringing conduct to any extent must be considered jointly and severally liable. In this case, the EU representative's role was that of a necessary intermediary for the sale of the infringed product in Italy, and its name is clearly visible on the packaging.
   
   
4. Furthermore, EU Directive 2004/48 (Article 11) and its transposition into the Italian IP Code (Art. 131, par. 1) allows for an injunction against intermediaries whose services are used for infringement.

The Court of Rome ultimately agreed with the trademark owner’s position. On July 11, 2025, it granted the appeal and issued an injunction against the EU representative, ordering that it definitively cease all activities that allow to the introduction, placing on the market and distribution of the infringing device and, in substance, that it no longer be designated as the EU representative for the disputed product. The Court of Rome also granted the applicant’s request that the appeal decision be communicated to the EUDAMED and the Italian Ministry of Health databases to ask for the removal of the name of the EU representative for the disputed device.

This decision is highly important for IP rights holders, because it confirms the joint liability of intermediaries, like the EU authorized representative within the definition of the Regulation on medical devices, whose role and services are essential for placing infringing products produced by non-EU manufacturers on the EU market, thus constituting an act of infringement. The identification of the intermediaries’ contribution to the infringement is an essential point for enforcement of IP rights, and the possibility for the IP holder to obtain a preliminary injunction against the EU representative separately from the manufacturer puts IP rights holders in a stronger position vis-a-vis non-EU manufacturers of infringing products.