The new EUDAMED registration service for the economic operators and medical and IVD devices has been officially operational since November 27, 2025 with the publication of European Commission Decision (EU) 2025/2371 in the Official Journal of the European Union.
To achieve full digitalization of the service, EUDAMED has granted a six-month transition period, and the four new key modules will be mandatory from May 28, 2026 (November 27, 2026 for “Legacy Devices” previously compliant with Directive 93/42/EEC and Regulation (EU) 2023/607). At the end of this period, from May 28, 2026, the use of the first EUDAMED modules will become legally mandatory for entities falling within the scope of MDR 2017/745 and IVDR 2017/746.
The European regulatory framework: from Articles 34, 122, and 123 of the MDR to Regulation (EU) 2024/1860
To understand the current situation, it is necessary to start from the structure of Regulation (EU) 2017/745. Article 122 provided for the repeal of several provisions of the previous Directives (90/385/EEC and 93/42/EEC et seq.) concerning the registration of devices and economic operators. This repeal, however, was contingent upon the effective operation of the electronic systems provided for in Article 33(3) of the MDR.
The mechanism governing the entry into force of these obligations is specified in Article 123(3)(d) of the MDR. According to this provision, the obligations relating to EUDAMED electronic systems apply from six months after the date of publication of the notice in the Official Journal of the European Union (OJEU) certifying the operation and compliance of the specific module. Until that time, the corresponding provisions of the old directives continue to apply regarding information on vigilance, clinical investigations, registration of devices and economic operators, and certification notifications.
The Italian Ministry of Health’s position: the transitional period and the dual option
In this evolving European context, the Italian Ministry of Health has intervened to clarify the operating procedures within the country in a press release updated to January 15, 2026, on its institutional website.
The press release confirms that, until the date of mandatory use of one or more EUDAMED modules, the corresponding provisions of the previous directives will continue to apply. However, a crucial point concerns the interpretation of national legislation. The Ministry emphasizes that Legislative Decree No. 137 of August 5, 2022 (Article 31, paragraph 5) does not require mandatory use of the National Database of Medical Devices in the period between the publication in the Official Journal of the notice of functionality of a EUDAMED module and the date on which its use actually becomes mandatory.
This clarification appears to have an immediate practical consequence, as it introduces a “dual option” phase. The Ministry clarifies that, until the use of the first four Eudamed modules becomes mandatory, those required to register (including Notified Bodies) can choose to register either in the National Database (in Italy, the Ministry of Health’s Repertory for supplies to public hospitals) or in EUDAMED.
It remains to be seen what the Ministry of Health’s position will be as this deadline approaches. It will be crucial to understand if and how the “double option” phase will be managed in the weeks leading up to May 26, 2026, and, above all, what impact it will have on tender procedures and public procurement. Given that EUDAMED is set to become the central repository for documentation, contracting authorities will need to adapt their systems and requirements, creating a direct link between the European database and purchasing procedures.
In this context, the creation of the new National Database referred to in Article 14 of Legislative Decree 197/2022 will also need to be evaluated. According to it the distributors who make available medical devices in Italy will be required to register in this database, operated by the Ministry of Health, providing their data and the identification of the devices present in EUDAMED in compliance with the unique device identification system (UDI system).
EUMED stands ready to support you through these uncertain times. With a full command of EUDAMED’s interoperability and data requirements, we can manage your device registrations efficiently through XML bulk uploads. Don’t waste precious time—reach out now for our support!