EUDAMED: European Databank 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?

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

  1. an interface allowing on-line data entry (by users)
  2. 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

For now, you can still lie back: the DIMDI enters data in Eudamed. The DIMDI states to transfer data biweekly. This means that only national authorities can and must (e.g. under Article 14a MDD) use Eudamed (since Mai 2011).

You continue to register your product with the DIMDI. Incidents must be reported to the BfArM.

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. 

Further Outlook

When reading Article 34, it becomes clear that this development may still take some time:

The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018. That plan shall seek to ensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2020 and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/746 are met.

Emergogroup on the further schedule:

"So, the MDR Eudamed may be ready for beta-testing by March 2018, operational by March 2019, formally functional in September 2019 and existing data entry will continue into March 2021."

Politics are probably the bigger challenge than technology. Yet the maintenance of the EU's website leaves a lot to be desired: the EU's information on Eudamed date from 2005 respectively from 2012 (evaluation).

Conclusion

There is no need to take immediate actions with respect to Eudamed. We can rely on the "speed" of government projects. However, you should not postpone your preparations for implementing the Unique Device Identification UDI system.

Author:

Prof. Dr. Christian Johner

Starter-Kit_rot_dunkel

A quick overview: Our

Starter-Kit

Learn More Pfeil_weiß
blog_rot_dunkel

Always up to date: Our

Institutejournal

Learn More Pfeil_grau