Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices referred to in Article 34(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council, was published in the Official Journal of the European Union on November 27, 2025.
The mandatory use of the four Eudamed modules (the electronic system on registration of economic operators, the UDI database and the electronic system for registration of devices, the electronic system on notified bodies and certificates, the electronic system on market surveillance) shall enter into force on May 28, 2026.
The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) maintain the Register of Medical Devices of manufacturers or their representatives established in the Republic of Slovenia. This register contains information on medical devices that comply with Council Directives 93/42/EEC and 90/385/EEC, Directive 98/79/EC, and Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
Manufacturer means a natural or legal person who manufactures or fully refurbishes a device, or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
Authorised representative means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer, located outside the European Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation.
Manufacturers and authorized representatives with a place of business in the Republic of Slovenia who must, prior to placing a device on the market, arrange for the registration of the device in the national medical device registry at JAZMP in accordance with Article 45 of the Medical Devices Act -1 or in the Eudamed medical device database, shall pay an annual fee in accordance with Article 6 of the JAZMP Tariff for Medical Devices (Official Gazette of the Republic of Slovenia, No. 6/26), link JAZMP Tariff for Medical Devices
