Search for devices or certificates for any registered (mandatory) medical device in the EU: EUDAMED is the centralized IT system established by the European Commission to facilitate the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), serving as the authoritative repository for medical device data in the European Union.
The platform integrates six functional modules—Actor registration, UDI/Device registration, Notified Bodies and Certificates, Clinical Investigations, Vigilance, and Market Surveillance—to enhance transparency and coordination across Member States. Following the functional declaration in late 2025 via Commission Decision (EU) 2025/2371, the first four modules become mandatory for all economic operators on May 28, 2026, consolidating the registration, notification, and dissemination of safety and performance data for medical technologies.
Can search by a notified body, vendors … finally!
It will improve transparency in the medical devices business, more safety and help to fight “strange” certificates or claims.
Quality, regulatory professionals and purchasers utilize EUDAMED to manage Single Registration Numbers (SRN) and ensure technical documentation aligns with the centralized UDI database for continuous market access:
- Validate the certification status and regulatory standing of international suppliers and manufacturing partners.
- Coordinate clinical investigation data to support performance validation and the technical files required for CE marking.
- Analyze vigilance reports and field safety corrective actions to mitigate technical failure modes in existing product lines.
- Standardize device labeling and data attributes according to the European Medical Device Nomenclature (EMDN).
