The European Commission (EC) issued long-awaited documents on two essential actions to implement the EU’s medical device and in vitro
diagnostic regulations (MDR/IVDR), namely the high-level functional specifications for Eudamed and its final assessment on the future nomenclature for the database.
The new documents comply with requirements that the 2017 regulations imposed on the Commission as part of the transitional periods to enter MDR and IVDR into force by 26 May 2020 and 26 May 2022, respectively, and repeal the current medical device and IVD directives. These requirements called for drawing up the functional specifications for Eudamed—the European database on medical devices—and making available a medical device nomenclature to support the revamped Eudamed.
Eudamed is referenced in about 50 articles in each regulation and is considered one of the cornerstones of MDR/IVDR.
The new documents suggest Eudamed projects are on schedule. The MDR-mandate Eudamed go-live date was set for 25 March 2020. Yet the EC estimated in its recently updated
MDR/IVDR rolling plan that “modules for clinical investigation and market surveillance might be only partly or not at all available at the time of application of the two regulations (due to workability issues) but few months after.”
The new regulations include provisions to widen the application of Eudamed, which will be open to more stakeholder groups, including the Medical Devices Coordination Group (MDCG), notified bodies (NBs), economic operators such as importers, non-EU competent authorities and the public. Its scope will be much larger under the new regulations and the extension will begin to incorporate unique device identification (UDI), accreditation and designation of NBs and market surveillance.
For the new databank to provide greater access and operate with a larger scope, MDR Eudamed will consequently require additional functionalities, including interoperability and artificial intelligence.
“The functional specifications are divided between the restricted website and the public website,” the EC explained. Some of the functional specifications covered by the document include UDI and market surveillance, among others.
The Eudamed document also identifies a set of project deliverables. These include producing mock-ups and prototypes in support of use case modelling, launching the restricted Webgate and the public Europa websites within Eudamed, providing user guides and training materials and establishing an application support team.
“The main expected outcome is that thanks to MDR Eudamed the implementation of the medical devices regulations will be de facto possible and successful, but also that the stakeholders with legal obligations will be able to comply with the regulations,” the EC said. Functional specifications each have an assigned timing priority: Most (159) are marked as medium, following by high (129). Only 22 are low priority.
The nomenclature aims to not only support the functioning of Eudamed, but also to standardize descriptions in and interpretations of its information to identify and monitor incidents and root causes.
A one-page EC document formally recognizes the 2018 document
developed by the MDCG. The MDCG document offered a snapshot of how the future nomenclature is expected to fulfill certain legal requirements and criteria. As part of the nomenclature project, the process will also entail establishing a taskforce of member states under the EU UDI workgroup, working with the taskforce to evaluate relevant Commission services and having the taskforce produce and provide a report to the MDCG.
The National Classification of Medical Devices (CND) nomenclature will be mapped to the Global Medical Device Nomenclature (GMDN) and made available in MDR Eudamed, according to the EC.
“The correspondence between the nomenclatures will be visible to operators and incorporated in the future database,” the EC said. “This will allow all operators registering their device to find CND nomenclature equivalent to a GMDN code.” Next steps include establishing an MDCG subgroup for oversight of the EU nomenclature system, exploring ways to support the nomenclature work
of the World Health Organization and providing additional details on the system’s governance and operation.
Eudamed Functional Specifications
, Medical Device Nomenclature
To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe