EC Explains What UDI Information to Provide for Eudamed

Regulatory NewsRegulatory News | 03 May 2019 |  By 

The European Commission on Friday released three documents, including two on the Medical Device Regulation (MDR) and the In Vitro Diagnotic Regulation (IVDR) and what data from the unique device identifier (UDI) needs to be included in the Eudamed database of devices and IVDs, and another document on the Eudamed device data dictionary.

In addition to the manufacturer name and Basic UDI-DI value, the MDR document notes the requirement of indicating if the device is implantable or a reusable surgical instrument, among other required information.

The IVDR document also notes the requirement for information on whether the IVD is for self-testing, or if it’s a companion diagnostic or a reagent or intended to administer or remove a medicinal substance, or for professional testing.

Meanwhile, the dictionary document, which is in the form of an Excel spreadsheet, describes what data should be provided to Eudamed and what can be communicated through the data exchange process for the UDI/Device module.

“The document presents the different attributes related to UDI/Device that may be communicated through XML, their correspondence to the fields from EUDAMED User Interface, the description of each field apart and the Rules applying at the level of the Entity of for each specific field apart,” the document says.

The documents come as last month, the EU’s Medical Device Coordination Group (MDCG) released two documents explaining how legacy devices can be registered in Eudamed without a UDI and how device companies will have until November 2021 to register device data elements in Eudamed.
MDR - UDI and device data sets to provide in EUDAMED

IVDR - UDI and device data sets to provide in EUDAMED

EUDAMED UDI Device Data Dictionary


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