Enter: Eudamed The original concept of a European databank formally was conceptualized more than

Enter: Eudamed

The original concept of a European databank formally was conceptualized more than 12 years ago in the In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC released in 1998. In fact, the IVDD included a clause that modified the Medical Devices Directive (MDD) 93/42/EEC to include a section on the databank. It was not until Directive 2007/47/EC, however, that operational timelines were introduced.
Just recently, the European Commission announced (Commission Decision, April 19) that Eudamed, the databank for medical devices, will become mandatory for all Competent Authorities in the European Union as of May 1, 2011. Until then, use of the databank is voluntary. It is important to note here, however, that the databank will not be accessible publically. Instead, access to Eudamed will be reserved for Competent Authorities and likely Notified Bodies and other national regulatory agencies.
The creation of Eudamed was in response to the growing need for a collective and shared post-market surveillance system. To this end, Eudamed will serve as a database that will collect details on incidents and, according to the European Commission, will “give an overview to every member state of the incident history of a device present on the market.” Related to this goal, Eudamed will include information on incidents or near-incidents of a particular medical device.

According to the European Commission, the following information will be captured by Eudamed:

• Registration of manufacturers, authorized representatives and devices;
• Data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused;
• Data obtained in accordance with the vigilance procedure; and
• Data on clinical investigations.

Please note in the last bulleted item above, that while the title of this column indicates that post-market surveillance efforts will be harmonized, as described above, details on clinical investigation also will be collected and unified.