In April 2017, the new EU Medical Devices Regulation passed by the European Parliament. After a transitional period of 3 years starting from 25 April 2020, it is mandatory for all medical device manufacturers.

The implementation of the EU regulation for medical devices is based on the requirements of the established solution of the FDA UDI and the GUDID database.

The European Commission published in 2019 already many technical details about data structures and data submission details. Based on these informations and of our existing knowledge on the UDI FDA solution, we build already a full functional SAP Add-On solution to maintain, migrate and export UDI data in SAP.

For the people who have already gained initial experience with the GUDID, the data fields of EUDAMED will appear only to be partly familiar. So there is also a device identifier, manufacturer information, risk class, direct marking, clinical Sizes and other similarities.

A major difference is that you can group very similar products that differ only in the UDI-DI attributes fields, for example only in color of the devices. This is the term “BASIC UDI“, which represents the product group. As shown in Figure 1, the attributes that are identical for all products in the group are entered below them.

In the area of ​​UDI-DI, the attributes of the respective product are entered.

SAP UDI Solutions based on FDA UDI/GUDID

Our UDI SAP solution for FDA has already been established more than 10 times. Customers with UDI Add-On Solution are very satisfied and could fullfill the requirement on the time could upload there device informations to the GUDID whithout delay. From the very beginning, the development department took care to ensure that the data structures are so flexible that an extension can be easily and quickly adapted by other authorities.

All other transactions for data management and data export can now be flexibly adapted to the new fields of EUDAMED.

The final version of the EUDAMED solution will be finalized as soon as the EU publishes the last details and opens the test data submission portal.


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