EUDAMED (European Database on Medical Devices)

EUDAMED (European Database on Medical Devices) is a centralized information technology system established by the European Union under the Medical Device Regulation (EU 2017/745) and the In Vitro Diagnostic Regulation (EU 2017/746). It serves as the primary digital infrastructure for registering medical devices and in vitro diagnostics marketed in the EU, tracking certificates issued by Notified Bodies, and, as its remaining modules go live, documenting clinical investigations and recording vigilance and post market surveillance data. EUDAMED is designed to enhance transparency by making certain information publicly accessible while providing regulatory authorities with comprehensive data for market oversight.

Before the current EUDAMED, information about medical devices marketed in the European Union was fragmented across national databases with varying structures, coverage, and accessibility. Its predecessor, used under the earlier medical device directives from 2011, was built to give national competent authorities access to device information rather than to inform the public. This made it difficult for regulators to monitor the device market comprehensively, for healthcare professionals to access device information, and for manufacturers to manage their regulatory obligations efficiently. EUDAMED is designed to address these problems with a single, interoperable system that supports the entire device lifecycle from registration through post market surveillance. For researchers, EUDAMED already gives public access to device registrations, Notified Body certificates and summaries of safety and clinical performance, and it is designed to add public information on clinical investigations and field safety notices once those modules are live; much of this was previously difficult or impossible to obtain systematically.

EUDAMED consists of six interconnected modules. The Actor Registration module records information about manufacturers, authorized representatives, importers, and other economic operators. The Unique Device Identification (UDI) and Device Registration module stores Basic UDI-DI and UDI-DI data, including device descriptions, classifications, and intended purposes. For implantable and class III devices, it also holds the summary of safety and clinical performance that the MDR requires the manufacturer to make public through EUDAMED. The Notified Bodies and Certificates module tracks the certificates issued by Notified Bodies to manufacturers, their status, and any restrictions or suspensions.

The Clinical Investigations and Performance Studies module is designed to record information about clinical investigations of medical devices (and, under the IVDR, performance studies of in vitro diagnostics) conducted in the EU, including the sponsor, the device, the design of the investigation, and its status. The Vigilance and Post Market Surveillance module is designed to capture serious incident reports and field safety corrective actions (FSCAs), which manufacturers are required to report. The Market Surveillance module supports coordination between national competent authorities.

The modules are not all in use. Regulation (EU) 2024/1860 amended the MDR and IVDR so that EUDAMED could be rolled out module by module: each module becomes mandatory six months after the European Commission publishes a notice in the Official Journal of the European Union confirming that it is fully functional. That notice, Commission Decision (EU) 2025/2371, was published on 27 November 2025 for four modules, so Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, and Market Surveillance have been mandatory since 28 May 2026. As of October 2026, the Vigilance and Post Market Surveillance module and the Clinical Investigations and Performance Studies module are still in development. Until each of them becomes mandatory, the arrangements that applied before continue for that information; for example, manufacturers report serious incidents to the national competent authority of the member state where the incident occurred, no later than 15 days after becoming aware of the incident (MDR Article 87(3); shorter limits apply to serious public health threats and to deaths).

Manufacturers are required to register their devices in EUDAMED and assign UDI identifiers following the UDI system administered by issuing entities such as GS1, HIBCC, ICCBBA, and IFA. Each device receives a unique identifier that enables tracking throughout the supply chain and facilitates recalls, adverse event reporting, and post market surveillance.

EUDAMED has a public site and a restricted site. The public site shows information from the live modules, including actor and device registration information, Notified Body certificate information, and summaries of safety and clinical performance. The MDR also provides for public access to most clinical investigation information (unless confidentiality is justified, for example to protect personal data or commercially confidential information) and to field safety notices, but that information will appear only once the corresponding modules are live. Other data, such as individual serious incident reports and market surveillance information exchanged between authorities, are accessible only to competent authorities, the European Commission and, in some cases, other authorized users.

EUDAMED is relevant for anyone involved in the development, regulation, or surveillance of medical devices in the European Union. Manufacturers use it to register themselves and their devices, and will use it to report serious incidents once the vigilance module is live. Notified Bodies use it to record and manage certificates. Competent authorities use it for market surveillance and, once the vigilance module is live, for vigilance monitoring. Researchers and systematic reviewers can use EUDAMED to check a device's registration, risk class and certificates, to read its summary of safety and clinical performance, and to understand the regulatory landscape for device categories they are studying; once the remaining modules are live, they will also be able to identify clinical investigations of medical devices and field safety notices for specific devices. Healthcare professionals and patients can access publicly available information about devices and their safety records.

A common error for manufacturers is underestimating the data requirements for EUDAMED registration, leading to delays and incomplete submissions. The UDI system requires detailed device identification at a level of granularity that many manufacturers' existing product data systems were not designed to support. Another mistake is assuming that EUDAMED has already replaced national systems: until the vigilance and clinical investigation modules become mandatory, serious incident reports and clinical investigation applications still go through national competent authorities, and registering in EUDAMED does not necessarily satisfy national requirements that some member states keep alongside it. Researchers sometimes treat the absence of a device or investigation from EUDAMED as evidence that it does not exist, when in fact the Clinical Investigations module is not yet live and devices already on the market were given a transition period to be registered. Finally, interpreting vigilance data from EUDAMED without understanding the reporting criteria and thresholds can lead to misleading comparisons of safety profiles across devices.

A research team conducting a systematic review of clinical evidence for a class III implantable device searches EUDAMED's public site in October 2026. The device's registration record confirms its Basic UDI-DI, risk class and Notified Body certificate, and gives access to its summary of safety and clinical performance, which summarizes the clinical evaluation behind the device's CE marking. Because the Clinical Investigations and Performance Studies module is not yet live, the team cannot search EUDAMED for investigations; it searches ClinicalTrials.gov and WHO ICTRP instead and follows up the clinical data described in the summary. The review's methods section records which EUDAMED modules were live on the search date, so readers can see that the absence of investigation records in EUDAMED reflects the roll-out, not an absence of investigations.