Source: Deutsche Nachrichten
28 November 2026 is the deadline for registering in EUDAMED medical devices and in vitro diagnostic medical devices that were already placed on the market before 28 May 2026 and for which further units continue to be placed on the market from that date, subject to the conditions and exceptions set out in the applicable legislation.
EUDAMED (European Database on Medical Devices) is the European database established to improve transparency, traceability and the sharing of information on medical devices and IVDs. The system centralises data on economic operators, devices and their associated certificates, facilitating coordination between manufacturers, authorised representatives, importers, notified bodies and competent authorities. For manufacturers, EUDAMED registration is a regulatory obligation that requires careful preparation of information and verification of its consistency with the technical documentation and applicable requirements. Incomplete, inaccurate or outdated information may lead to issues during regulatory checks.
In this context, TentaConsult Italia, the consultancy company within Tentamus Group Italia, supports companies in reviewing the regulatory status of their devices, identifying the registrations required and preparing the information to be entered into the system. This support combines documentation review with the operational management of registrations, including assistance with subsequent data updates.
Which devices does the deadline apply to?
The deadline covers both devices compliant with the MDR and IVDR and “legacy devices” placed on the market under the transitional provisions relating to the previous Directives, provided they meet the conditions set out in the applicable legislation.
As clarified in the European Commission’s guidance, this is not a general extension. For new MDR and IVDR devices subject to the registration requirement, where the first unit is placed on the market on or after 28 May 2026, registration must take place before that unit is placed on the market.
The European Commission also specifies that a legacy device does not require a separate registration where the same device has already been registered as MDR- or IVDR-compliant, in accordance with the identification criteria set out in the document. Reviewing existing registrations is therefore relevant to correctly identifying the applicable obligations.
The regulatory framework
The gradual roll-out of EUDAMED is governed by Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), as amended by Regulation (EU) 2024/1860. Decision (EU) 2025/2371 declared the first four modules functional, with their use mandatory from 28 May 2026.
From documentation to registration
TentaConsult Italia’s support begins with a review of the device’s regulatory status, the available documentation and the applicable obligations. It continues with identifying the registrations required, planning activities and assisting with data collection and the management of EUDAMED registrations.
Assistance also covers the registration of economic operators, including manufacturers, EU authorised representatives, importers, and system and procedure pack producers. TentaConsult Italia supports companies in reviewing company data and documentation, applying for the Single Registration Number (SRN), the operator’s unique identification number, and throughout the validation process.
Services also include support with implementing and managing the Unique Device Identification (UDI) system, reviewing device classification under the MDR/IVDR, entering information and checking its consistency with the technical documentation and platform requirements. Assistance extends to regulatory updates and changes to registered data, supporting companies beyond the initial registration.
For manufacturers, the service therefore combines operational registration support with documentation review and the ongoing maintenance of information.
Learn more about the national and EUDAMED registration service and explore TentaConsult Italia’s full range of Medical & Regulatory solutions.