Important notice: The following information is not completely up to date (due to the current dynamic situation) and is currently under revision.
You will find all current information concerning the implementation and the development of the European database EUDAMED on the webpage of the European Comission.
Eudamed (existing database according to EU directives for medical devices)
The European Commission obligates the EU Member States to use the Eudamed databank as of 1 May 2010 (resolution from 19 April 2010). Thereby all data collected on an individual state level thus far that are required according to the Directives 90/385/EEC, 93/42/EEC and 98/79/EC, will be centrally combined:
- Notifications about manufacturers, authorised representatives and products
- Data in the context of certificates (issued, changed, complemented, suspended, withdrawn or refused)
- Data in accordance with monitoring procedures and vigilance reporting
- Information on clinical investigations
The quick access by the competent authorities to this information is intended to improve market surveillance.
Eudamed exists as a secure web portal for the exchange of information between the national authorities. Here they can submit and retrieve data. Manufacturers, notified bodies or the public do not have access.
German data submission to Eudamed
According to § 33 Medical Device Act, the team for the Medical Devices Information System of BfArM provides the required data from the national Medical Devices Information System for the European databank. To accomplish this, the former German Institute of Medical Documentation and Information (DIMDI) has developed a software for the XML upload from the national databanks. The current German data will be transmitted to Eudamed weekly.
Development of Eudamed
Between 1997 and 1999 DIMDI successfully developed the first version of Eudamed in the context of an EU project.
In 2000, however, the EU Commission decided to take on the responsibility for the European databank. It set up Eudamed with the Directorate-General for Enterprise and Industry. Since January 2004 the competent authorities have been able to access the databank. Some EU Member States, esp. those lacking their own national systems, have begun to provide their data to Eudamed on a voluntary basis. However, since no binding agreements regarding the delivery process and data set existed, the database was not developed further.
Not until 2006 did the EU Commission begin to expedite the rebuilding and operation of Eudamed. A new software version (Eudamed 2) was approved at the end of 2009. In July 2010, Eudamed migrated from the Directorate-General for Enterprise and Industry to the Directorate-General for Health and Consumers and in 2014 to the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs.
The EU Commission currently develops a new European database Eudamed to fulfil the requirements of the new EU Regulations for medical devices and in vitro diagnostics, which came into force in May 2017.
BfArM represents the German interests in different international Eudamed Working Groups coordinated by the EU Commission.