EC Releases New Batch of MDR Eudamed Guidelines

Regulatory NewsRegulatory News | 29 May 2019 |  By 

In the latest batch of documents on Eudamed under the EU’s medical device regulation (MDR), the European Commission (EC) issued guidelines on data exchange solutions and data exchange services.

A 7-page document sets forth new guidelines to aid decision-making among competent authorities, notified bodies and economical operators, including device manufacturers and authorized representatives, on data exchange solutions for compliance with MDR’s future version of Eudamed.

“Although Eudamed offers multiple ways of inputting/downloading data, there are several parameters to take into account before making a decision,” the EC says. The factors identified in the document will help “in assessing the most cost-efficient solution for their needs to comply” with MDR’s requirements. 

The document provides an overview of the requirements specific to three data input methods—user interface (UI), XML upload/download via the Eudamed UI and the machine-to-machine system (M2M).

The simplest option is that of UI in terms of data handling, manipulation and implementation as it only requires a PC and a browser to connect to Eudamed online. Yet the second data input method is expected to be useful when MDR Eudamed goes live to upload data in bulk using the XML format.

The “most complex and costly solution” is automatic data exchange, otherwise known as M2M. It “should only be considered” under a specific set of conditions. Such conditions relate to whether the amount of data can be entered manually, frequent exchanges of information between systems are expected, cost of manual input versus cost of automation and resources for system implementation and maintenance.

Separately, a 26-page document addresses high-level architecture and data modeling to perform M2M Eudamed data exchange using the eDelivery building block of the Connecting Europe Facility. Its introductory guidelines seek to enable an interoperable exchange of electronic data and documents.

The introductory guidelines on Eudamed data exchange and entity models point to five concepts as key in understanding M2M connectivity: entity model, service model, data exchange and service definition.

The guidelines were released Wednesday along with a separate EC document that defines types of M2M data exchange services, including basic unique device identification (UDI) service, among others. They follow on the heels of three documents from earlier this month on UDI data that Eudamed must include.

Editor's note: We've removed the word "Drops" from the headline and added "Releases" to increase clarity.


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