Institute within the scope of the Federal Ministry of Health (BMG)
Institute within the scope of the Federal Ministry of Health (BMG)
For the European medical device market we are providing you with information regarding:
In addition, you will find links to contact addresses, legislative texts, directives, guidelines and harmonized standards.
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:
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.
According to § 33 Medical Device Act, the German Institute of Medical Documentation and Information (DIMDI) provides the required data from the national Medical Devices Information System for the European databank. To accomplish this, the DIMDI has developed a software for the XML upload from the national databanks. The current German data will be transmitted to Eudamed every 14 days. Only once the EU Commission has created the technical conditions for a fully automatic delivery can the DIMDI transmit current data on a daily basis.
Between 1997 and 1999 the DIMDI successfully developed the first version of Eudamed in the context of an EU project.
In 2000, however, the 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.
The international Eudamed Working Group meets twice a year at the EU Commission. The DIMDI represents the German interests there. The decisions of this work group are taken into consideration by the EU Commission during the on-going development of Eudamed.
The Medical Devices Unit of the EU Commission is located at the Directorate-General for Health and Consumers. It provides detailed on-line information about the legal framework for access to the European market as well as trade relations in the medical devices sector within the European Union. Aside from essential directives, guidelines (MEDDEV), manuals or consensus documents can be found that were created by members of the Medical Devices Expert Group (MDEG) d. Useful contact information completes the offer.
The European Commission – Medical devices