EUDAMED: European Databse on Medical Devices
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.
Find out:
- Which Purpose Does the EU Pursue with EUDAMED?
- Which Data Is Stored in EUDAMED?
- With Which Interfaces is EUDAMED Equipped?
- What Should You Know as a Medical Device Manufacturer?
Which purpose does the EU pursue with Eudamed?
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.
What Data is Stored in Eudamed?
The decision mentioned previously also determines which data EUDAMED must contain:
Actor (manufacturer/authorized representative)
- Name
- Street
- Locality
- Postcode
- Country
- Phone or E-mail
Device
- Nomenclature code
- Device name/make
- Additionally, the MDR requires under Article 24 and Part A Section 2 of Annex V the following: risk category, reusable device (yes/no), containing animal or human tissue (yes/no) etc. and the UDI
- Certificate
- Certificate number
- Certificate type
- Date of Issue
- Expiration Date
- Manufacturer and, if applicable, authorized representative (see fields under Actor)
- Notified Body (selected from system)
- General scope description and, where applicable, details on device (see fields under Device)
- Status and, where applicable, reasons for decision of notified body
Incident
- Competent authority reference
- Manufacturer and, if applicable, authorized representative (see fields under Actor)
- Manufacturer contact
- Manufacturer reference/Field Safety Corrective Action (FSCA) number
- Device (see fields under Device), plus where applicable lot number, serial number, software version (selected from system)
- Device known to be in the market in
- Confidential
- Complete investigation
- Background information (description)
- Conclusion
- Recommendation
- Action and action description.
Clinical Investigation
- Manufacturer, where applicable authorized representative (see fields under Actor)
- Device (see fields under Device)
- Title of investigation
- Protocol number
- Primary objective
- Competent authority contact for this clinical investigation
- Decisions taken by competent authority
- Date of decision and grounds
- Early termination on safety grounds
- Date of decision and grounds
The Commission Decision uses the term "databank" and not "database".
Which Interfaces is Eudamed Equipped With?
Eudamed is equipped with
- an interface allowing on-line data entry (by users)
- an interface enabling the up-loading of XML files.
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:
- Why is a file upload still used in the 21st century? Have you ever heard of REST?
- Why does the EU specify technologies?
- As the EU determines specifications, then why only partially? Without specifying a scheme file, the demand for a XMLl interface has no value.
- Are fields such as "primary objective" or "device known to be in market in" free-text field?
- Why does it take nearly 20 (!) years to develop such a database? One may even discern misgiving between the lines on DIMDI's website. There is no sight of an end to the development (see below).
What Should You Know as a Medical Device Manufacturer?
Status Quo
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.
Conclusion
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.
Author:
Prof. Dr. Christian Johner
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