The European Commission, by its decision dated 26 November 2025, confirmed the functionality of four modules within the European database on medical devices (EUDAMED).
EUDAMED collects and shares information on medical devices and in vitro diagnostic medical devices. It consists of a number of electronic systems; four of these, “registration of economic operators”, “UDI database and registration of devices”, “Notified Bodies and certificates”, and “market surveillance”, have been completed and confirmed as meeting the required functional specifications under the new regulations: the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). This confirmation triggers a six-month transition period for their mandatory use, which will begin on 28 May 2026.
EUDAMED
The creation of EUDAMED is one of the key aspects of the MDR and IVDR. It is intended to provide information on the overall life cycle of medical devices, as well as the economic operators that supply them—this information has not previously been publicly available for devices in the European Union. The database aims to enhance transparency of information on medical devices, including through better access to information for the public and healthcare professionals, and to enhance coordination between member states. It is intended to be a one-stop-shop to register devices and certificates across the European Union, which will reduce administrative burden, increase transparency and traceability, and strengthen market surveillance.
Under the MDR and IVDR, the obligations and requirements that relate to EUDAMED apply once the Commission has verified the full functionality of the relevant module and published a notice to that effect. However, the development of EUDAMED has been delayed a number of times. This has also had a knock-on effect on the application of some other parts of the regulations, such as the coordinated assessment of clinical investigations. This confirmation is therefore a major milestone for the European medical device regulatory framework and a key step in the implementation of the regulations.
From May 2026, it will be mandatory to comply with the relevant obligations for the operational modules, including registration of all devices prior to the first placing on the market, with details on the unique device identifier (UDI), registration of economic operators, and verification of these registrations by others in the supply chain. There will also be obligations on notified bodies and competent authorities to provide information about device.
Future Developments
The delays associated with the new legislative framework go beyond EUDAMED. The regulations are often criticised due to the regulatory burden and delays associated with demonstrating compliance with the new requirements, which has led to the withdrawal of some devices from the market.
In October 2024, the European Parliament called on the European Commission to amend the legislation. While this was not binding, in December 2024, the Commission launched a consultation, and in September 2025, a “call for evidence” with the aim of publishing amendments to the regulations in 2025. These revisions are expected to provide “targeted simplification” of the MDR and IVDR and pave the way for “a more efficient and predictable system”. Further updates are expected in the coming weeks and months.