As it prepares to meet new regulatory requirements in Europe, the medical device community is following developments regarding the European Database for Medical Devices (Eudamed).  Most recently, the European Commission (EC) released three documents for Medical Device Regulation (MDR) and In Vitro Diagnotic Regulation (IVDR) outlining what data from the unique device identifier (UDI) needs to be included in the Eudamed database of devices and IVDs.   The EC also provided a Eudamed device data dictionary.

 

Key Takeaways

MDR document: The medical device manufacturer name and Basic UDI-DI value remains a requirement.  But the EU has expanded the requirement necessitating that manufacturers note if the device is implantable or a reusable surgical instrument.

 

IVDR document: Manufacturers are now required to provide added information on whether the IVD is for self-testing, companion diagnostic, reagent, for professional testing or if intended to administer or remove a medicinal substance.

 

Dictionary document: This document is provided in an Excel spreadsheet and describes what data should be provided to Eudamed.  It also specifies what can be communicated through the data exchange process for the UDI/Device module.

 

According to the EU, “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 documents can be accessed with the following links:

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