LD Hamburg, October 21, 2025, order in the proceedings for provisional measures, UPC_CFI_553/2025

To establish jurisdiction, at least the plausible allegation of infringing acts in the country in question is necessary. A situation of imminent infringement may be characterised by certain circumstances which suggest that the infringement has not yet occurred, but that the potential infringer has already set the stage for it to occur. As a CE marking is required for placing a medical device in any of the EU Member States (Art. 5.1, Art. 5.3 (EU) Regulation 2017/745 on medical devices), obtaining such a CE-mark approval provides an indication of an expected market entry in any of the EU Member States in the foreseeable future. In the present case, the defendants have set the stage to market the attacked medical devices by obtaining (and publicly announcing) CE-mark approval for the attacked (implantable) medical devices, providing “ordering information” and announcing to show-case their products on a trade fair.

With regard to the urgency assessment, LD Hamburg considered that the CE-mark approval is a prerequisite for legally marketing a medical device in the EU Member States. Therefore, the general knowledge of the applicant of the attacked medical devices is not relevant as long as their marketing in the EU could not have been considered imminent due to the lack of the CE-mark. Gaining knowledge of the CE-mark approval is the starting point for the applicant to investigate the situation, take the necessary measures
to clarify it and obtain the documents required to support its claims.