European Database on Medical Devices (EUDAMED)

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https://ec.europa.eu/tools/eudamed/#/screen/home

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).

Disciplines: Medical devices, Regulatory affairs, Quality engineering, Biomedical engineering, Compliance.

Free alternative to FDA GUDID, Emergo database.

European Database on Medical Devices (EUDAMED) compared with FDA GUDID and Emergo database (typical)
European Database on Medical Devices (EUDAMED)	FDA GUDID	Emergo database (typical)
Scope and operator: EUDAMED is the European Commission system for medical devices and in vitro diagnostics on the EU market. It holds data on economic operators, devices, notified bodies and certificates, and market surveillance.	Scope and operator: GUDID is a database run by the US FDA within the Unique Device Identification system. AccessGUDID, the search portal, was created by the National Library of Medicine with the FDA.	Scope and operator: Checked member: the RAMS suite of Emergo by UL, a commercial regulatory intelligence service. It combines tools such as Product Classification, Registration Tracker, Regulatory Watch and Regulatory Reports instead of being a register filled by manufacturers.
Data content: The Device module is a register of devices placed on the EU market, linked to actor registration (including the Single Registration Number) and to certificates from notified bodies.	Data content: GUDID stores only the Device Identifier part of the UDI, with fields such as device name, company name, MR safety status, GMDN term and code, and premarket submission numbers. Lot and serial numbers are not stored, and there is no patient information.	Data content: The content is guidance and tracking: classification questions, regulatory updates and guidance filtered by market, registration and certificate records, and process charts with FAQs. It is not an official device register.
Nomenclature and search keys: The public Device module can be searched by manufacturer, SRN, model, trade name, risk classification, UDI-DI, Basic UDI-DI, medical purpose, EMDN code and device type attributes such as software, sterile or implantable.	Nomenclature and search keys: Devices carry a GMDN term and code, and the GMDN status is Active or Obsolete. FDA product codes are being removed so that GMDN codes remain the only option.
Access and cost: Public search of the Device module is open, as described by Emergo. Economic operators must register actors and devices to take part.	Access and cost: AccessGUDID is available to anyone, including patients, providers, hospitals and industry. FDA also mentions an openFDA UDI endpoint that includes GMDN fields.	Access and cost: Emergo lists a complimentary account and a free Global Fee Finder tool. Paid bundles are Emergo Pro (5 licensed users, Regulatory Reports for 3 markets) and Emergo Pro+ (10 users, unlimited markets). Prices are not listed on the page.
Submission and deadlines: The Actor registration, UDI/Device registration, Notified bodies and certificates, and Market surveillance modules become mandatory on 28 May 2026. Legacy devices have until 28 November 2026, and older certificates until 28 May 2027. Devices placed on the market from 28 May 2026 must be registered before the first unit is placed.	Submission and deadlines: Device labelers submit the data, either one device at a time in the GUDID web application or in bulk as HL7 SPL files through the FDA Electronic Submissions Gateway. Each record must pass the GUDID business rules.

Topics covered: EUDAMED, medical devices, Regulation (EU) 2017/745, Regulation (EU) 2017/746, Actor registration, UDI/Device registration, Notified Bodies, Certificates, Clinical Investigations, Vigilance, Market Surveillance, Single Registration Numbers (SRN), CE marking, European Medical Device Nomenclature (EMDN), transparency, safety, technical documentation, vigilance reportsISO 13485, ISO 14971, ISO 9001, IEC 62366, and EN 45501..