After months of criticism of the European Commission for the slow release of guidance on the EU’s new medical device regulations, the Commission released a flurry of documents on the Eudamed data exchange.
The guidance notes that there are several entry points for inputting and downloading data into the Eudamed database:
The manual user interface model is the simplest option from a data handling, manipulation, and implementation perspective, because the user only needs a computer and an internet connection.
The guidance notes that the machine-to-machine option “may be too costly” considering the many architectural, technological and operational issues, if the frequency and volume of the data transfer remains low.
The data exchange model is the most complex. Because it allows a bulk download of sensitive data, the application connected to Eudamed will need to comply with a “series of security requirements,” the Commission said. This solution should only be considered if the amount of data to be uploaded or downloaded can’t be entered manually, and there will be frequent exchanges of data between systems.
The guidance provides a decision tree to help authorized representatives or importers, devicemakers on which option makes the most sense to meet their compliance duties. Another decision tree is provided for notified bodies to make its determinations.
The Commission also released a separate document offering technical details on data exchange related architecture and data modeling for performing M2M connectivity.
This document covers high-level concepts such as the entity model, the service model the data exchange communication patterns and service definitions.
In May, The European Commission released new details on the datasets devicemakers should include in the Eudamed database for unique device identifiers under the new MDR and IVDR. The overriding principle for the database is that each UDI device identifier (DI) inherits the attributes of its linked Basic UDI-DI—the primary identifier of a device model and the main key for records in the UDI database that’s referenced in certificates and EU declarations of conformity (IDDM, May 10).
Read the Eudamed Data Exchange Guidelines here: www.fdanews.com/06-06-19-Eudamed.pdf.