Commission Decision (EU) 2025/2371 was published in the Official Journal of the European Union on November 27, 2025, on the functionality and compliance with the functional specifications of certain electronic systems included in the European database for medical devices referred to in Article 34(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council.
Four Eudamed modules (the economic operator registration module, the medical device registration module, the notified body certificate registration module, and the market surveillance module) have entered into force on May 28, 2026.
A manufacturer means a natural or legal person who manufactures or fully processes a device, or who commissions the design, manufacture, or full processing of a device, and who markets that device under their own name or trademark.
Authorized representative means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer located outside the Union to perform, on its behalf, specific tasks related to that manufacturer’s obligations under this Regulation.
The Eudamed medical device registration module is now available, and we urge manufacturers to register their devices in Eudamed. The transition period for registering devices in Eudamed ends on November 28, 2026. By that date, all devices compliant with the regulations, must be registered in Eudamed.
Manufacturers and authorized representatives with a place of business in the Republic of Slovenia shall pay an annual fee in accordance with JAZMP Tariff for Medical Devices (Official Gazette of the Republic of Slovenia, No. 6/26), link JAZMP Tariff for Medical Devices
