The European Commission released long-awaited guidance on Eudamed (the European Database on Medical Devices) and the device nomenclature system that will be used for the EU’s new medical device and in vitro diagnostic regulations.
The document is the first draft guidance the commission has released that provides details the functional specifications of the Eudamed database for devices and IVDs. The new regulations go into effect on May 26, 2020 for devices and on May 26, 2022 for IVDs.
Eudamed is “a keystone for the implementation of the new regulations,” enabling device traceability and better market surveillance, the commission said.
The guidance covers legal requirements for stakeholders, including unique device identifiers, clinical investigations, vigilance, and specific requirements for manufacturers, notified bodies and other actors.
The Eudamed system includes a public website for anonymous users to search and view publicly available data and a restricted website for database content management with access to all data an authorized user has the right to access.
Distributors and importers that assume the obligations of device manufacturers also assume responsibility for unique device identification labeling, the commission said. This means that distributors and importers must apply for registration as manufacturers and receive a single registration number, according to Article 16 of the device regulations (IDDM, Oct. 26, 2018).
However, if the manufacturer is identified on the label rather than the distributor or importer, the manufacturer is responsible for meeting the UDI obligations under the quality system regulation. Released by the Medical Device Coordination Group (MDCG), which is comprised of representatives from all EU member states, the guidance clarifies roles and responsibilities for device and IVD manufacturers.
The commission also released guidance on device and IVD nomenclature to support the Eudamed database and to serve as a reference throughout the decision process. The guidance was developed in cooperation with the MDCG, and the EC adopted the proposals that the MDCG had floated in 2018.
The EC said the Italian National Classification of Medical Devices (CND) nomenclature will be mapped to the Global Medical Device Nomenclature (GMDN) and will be made available in the future Eudamed.
“The correspondence between the nomenclatures will be visible to operators and incorporated in the future database,” the commission said. “This will allow all operators registering their device to find CND nomenclature equivalent to a GMDN code.”