CE Marking
EUDAMED Registration
European Database on Medical Devices
Applies to: Manufacturers, authorised representatives and importers
What Is EUDAMED Registration and Why It Matters?
EUDAMED (European Database on Medical Devices) is the official centralized database established under EU Medical Device Regulation (MDR 2017/745) to enhance transparency, traceability, and regulatory oversight of medical devices placed on the European Union market. Registration in EUDAMED is a mandatory regulatory obligation for manufacturers, authorized representatives, importers, and medical devices subject to MDR requirements.
EUDAMED registration provides structured and verified information on economic operators (actors), medical devices and UDI data, certificates, clinical investigations, and post-market surveillance and vigilance activities, enabling competent authorities and stakeholders to effectively monitor device compliance and safety throughout the product lifecycle.
All manufacturers irrespective of whether the device is Class I, IIa, IIb, or III are required to register the relevant actor information and device data in EUDAMED prior to placing the device on the EU market, in accordance with MDR Articles 29, 31, and related implementing acts. Without proper EUDAMED registration, lawful market placement and continued EU market access is not permitted.
How Can We Help?
Our experts support manufacturers throughout the EUDAMED registration process, including SRN application, economic operator (Actor) registration, UDI-DI and device data submission, and alignment with the Technical File, ISO 13485:2016, and Notified Body expectations ensuring regulatory compliance, data consistency, and a smooth pathway to CE marking and sustained EU market presence under the oversight of the European Commission.
FAQ
EUDAMED — frequently asked questions
EUDAMED (European Database on Medical Devices) is the central EU database introduced under MDR and IVDR to improve transparency, traceability, and regulatory oversight of medical devices and IVDs. Registration in EUDAMED is a core regulatory obligation for manufacturers, authorized representatives, importers, and devices placed on the EU market.
EUDAMED registration applies to:
- Medical device manufacturers
- IVD manufacturers
- EU Authorized Representatives
- Importers
- System and procedure pack producers
Each economic operator must register separately and maintain accurate, up-to-date information.
Yes. MDR and IVDR require economic operators and devices to be registered in EUDAMED. In practice, without proper EUDAMED registration, CE marking, market access, and interactions with Notified Bodies are significantly restricted.
Yes. Devices transitioning from MDD or IVDD to MDR or IVDR must be registered in EUDAMED according to the applicable timelines and transitional provisions. Many manufacturers underestimate this requirement during MDR/IVDR transition.
EUDAMED is not a simple administrative step; it is a regulatory system tightly linked to MDR and IVDR compliance. Errors can trigger audits, delays, or corrective actions. Professional support reduces risk and ensures long-term regulatory stability.
EUDAMED is not a simple administrative step; it is a regulatory system tightly linked to MDR and IVDR compliance. Errors can trigger audits, delays, or corrective actions. Professional support reduces risk and ensures long-term regulatory stability.
EUDAMED
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