Eudamed and Global Medical Device Nomenclature (GMDN)
The European Commission decided on April 19, 2010 to formally launch the European Databank of Medical Devices (Eudamed) on May 1, 2011. Eudamed contains data on:
- ‘Actors’ (manufacturers and authorised representatives);
- Devices (Active Implantable Medical Devices, Medical Devices and In-Vitro Diagnostic Medical Devices);
- Certificates (issued by Notified Bodies);
- Incidents (only the National Competent Authority Reports);
- Clinical Investigations.
Only the European Commission and the European Competent Authorities can enter data or get access to data entered by others.
The creation of Eudamed was in response to the growing need for a collective and shared post-market surveillance system. Directives 90/385/EEC on active implantable medical devices, 93/42/EEC on medical devices, and 98/79/EC on in-vitro diagnostic medical devices contain articles requiring such a database. To this end, Eudamed serves as a database that collects details on incidents and, according to the European Commission, "contributes to a uniform application of those Directives, in particular in relation to registration requirements." Related to this goal, Eudamed includes information on incidents or near-incidents of a particular medical device that are considered to be of importance to other Member States.
Global Medical Device Nomenclature
Exchange of information within a database like Eudamed requires unambiguous device descriptions. To that aim, the Global Medical Device Nomenclature (GMDN) has been translated in 20 member states’ languages. GMDN provides the so-called ‘preferred terms’ that will refer to a specific type of device and can be identified by a single five-digit code. The GMDN database of preferred terms is managed by the GMDN agency. One of the drawbacks of GMDN is the fee users must pay for every term they upload. Therefore there are other global nomenclature systems that compete with GMDN that further hamper its introduction.
Eudamed in practice
For manufacturers, the introduction of Eudamed simplified notification procedures. It is no longer required to register all in-vitro diagnostic devices in every member state before marketing in a Member State. Class IIa, Class IIb, and Class III medical devices only must be notified in Member States that require this registration in their transposition of the Medical Devices Directive.
A survey amongst the Member States, published in October 2012, provides insight in how these main users experience Eudamed. Although they access Eudamed to search data on Actors and Devices and they exchange vigilance data with other member states through Eudamed, there is room for improvement:
- There are indications of under reporting as one Member State had entered more then 10,000 actors and 11 Member States recorded less then 100. The same goes for the numbers of devices, where two Member States recorded more than 50,000 devices each and 10 recorded less then 500.
- Of the 28 member states, five recorded more than 100 NCAR’s, while 13 reported nothing.
- A sample of data entered after May 2011 was found to be accurate in 92% of the samples; 6% of mandatory fields were fulfilled with ‘NA’. On average, 42% of the optional fields were used.
- Where the accuracy of data for NCAR’s and Clinical Investigation reached a 100% accuracy, actors and devices were accurate in 90% of the cases and the certificates module in 80%.
- In 2012, just over a third of the Member States reported they were using Eudamed for market surveillance for making decisions regarding clinical investigations. And a significant minority didn’t use Eudamed for searching modules.
- The transposition of the Directives into national law appears to be heterogeneous, leading to national databases that are not fully reflected in the Eudamed data.
In conclusion, Eudamed works and has an added value. But it is also clear the current Eudamed doesn’t meet expectations. It is expected that the Regulations will result in developing Eudamed into a comprehensive and transparent database for medical devices.