EUDAMED, the European Databank for Medical Devices, attends to the administration of medical devices. The Medical Device Regulation relies on Eudamed, imposing further requirements on it.
EUDAMED stems from the EU Commission Decision 2010/227/EU in which the EU frames the aim of EUDAMED:
"The aim of the European databank for medical devices is to strengthen market surveillance by providing competent authorities with fast access to information on manufacturers and authorized representatives, devices and certificates and to vigilance data, to share information on clinical investigation data, as well as to contribute to a uniform application of those Directives, in particular in relation to registration requirements."
This decision of April 2010 was issued at the same time as the ban on breast implants of the manufacturer PIP.
The decision mentioned previously also determines which data EUDAMED must contain:
Actor (manufacturer/authorized representative)
The Commission Decision uses the term "databank" and not "database".
Eudamed is equipped with
The EU even determines the protocol (https).
The products' codification relies on GMDN, the Global Medical Device Nomenclature, which is a global nomenclature for medical devices based on EN ISO 15225:2000.
Welcome to the Last Millennium
As a developer, one may ask:
Up to now, only the actors registration module is available.
In March 2021, the EC has updated the release schedule:
The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by September 2021. Afterwards, the remaining modules will be displayed as soon as they are functional
MDR and Eudamed
The Medical Device Regulation MDR requires under Article 29: Before placing a device on the market, other than a custom-made device, the manufacturer shall enter or if, already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof, and shall thereafter keep the information updated.
For products classified as class III and for implants, Article 32 additionally requires entering a summary of the device's main safety and performance aspects in Eudamed.
The database (in parts) shall also be publicly available.
The first module of Eudamed is functional since December 2020. We recommend to proceed with the actor registrations, in order to obtain the SRNs. And finally, you should not postpone your preparations for implementing the Unique Device Identification UDI system.