The original concept of a European databank formally was conceptualized 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.
The European Commission announced (Commission Decision, April 19, 2010) 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- Data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused;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 article indicates that post-market surveillance efforts will be harmonized, as described above, details on clinical investigation also will be collected and unified.
Impact of Eudamed
For manufacturers, the introduction of Eudamed will simplify both post-market surveillance and notification procedures. For example, in-vitro diagnostic (IVD) manufacturers marketing within the European Union currently are required to separately notify each Competent Authority in every market in which their products are sold. In a less onerous approach, Class IIa, Class IIb and Class III manufacturers only must notify a Competent Authority if that member state in their transposition of the Medical Device Directive 93/42/EEC required notification. In contrast, device manufacturers of Class I devices only must notify the Competent Authority in the country in which they are based (or their Authorized Representative is based). Thus, the introduction of Eudamed will impact manufacturers, particularly IVD manufacturers, that will no longer be required to notify each Competent Authority separately if they intend to market their product there.
Another likely outcome of the implementation of Eudamed and a single, unified databank is the reduction of risks due to known device-related incidents or malfunctions that have occurred in other markets. To clarify, at present without a shared databank, a time lag exists in the communication of device-related issues to the appropriate regulatory body in multiple markets. With the use of Eudamed, notification efforts will be streamlined, resulting in a more timely and efficient process, thus reducing the risk of repeat issues. It is envisioned that Eudamed will facilitate reporting of Field Safety Corrective Actions as well.
Global Medical Device Nomenclature (GMDN)
One element required for Eudamed's success is a translation of the GMDN codes and terms into the more than 20 different languages of the European Union. Until now, the use of GMDN had not been harmonized completely because the terms were not available in all of the languages used throughout the European Union and, therefore, not all member states chose to adopt GMDN.
To address this issue, the European Commission has prioritized translations of GMDN codes and terms. As a result of the European Commission's endorsement of GMDN, the GMDN Agency has issued new and translated terms at a tremendous rate. In response to the European Commission's undertaking of GMDN translations, the GMDN Agency has noted that the action would "remove the last barrier for the implementation of the EU post-market vigilance system."
GMDN Codes Explained
According to the GMDN Agency, GMDN codes are used to assign each medical device or IVD with "... a single naming system that will support patient safety. Information in the form of a code is provided to indicate the generic descriptor within which the device can be identified, by reference to a globally accepted generic medical device nomenclature (the GMDN) so that other particular devices having substantially similar generic features but coming from another source can be identified, for reasons of data exchange between competent authorities and others, exchange of post-market vigilance information and inventory purposes."
In addition, as defined by the GMDN Agency, preferred terms are those that "describe devices having the same or similar intended use or commonality of technology [and are] the only terms by which medical devices can be classified."
Interestingly, as a result of the implications of Eudamed on IVD manufacturers, there is an increasing demand for new and translated preferred terms for IVDs. Currently, the GMDN terms cover mostly medical devices. It will be interesting to follow the growth of the GMDN Agency's published terms, which is now expanding to include IVDs. Access to the GMDN terms is available to GMDN members. There are fees associated with membership, though reduced fees are available for smaller manufacturers (which are those who have less than 1 million euros in annual sales).
The Global Harmonization Task Force advocates the use of GMDN throughout the European Union; interestingly, the origin of GMDN was sponsored by the European Commission in response to the standard EN ISO 15224. GMDN codes and terms are used internationally, and industry officials hope that the GMDN will become the nomenclature scheme adopted by countries worldwide.