SAP UDI Solution for the EU Medical Devices Regulation and EUDAMED
Already in April 2017, the EU Medical Devices Regulation was passed by the European Parliament and is mandatory for all medical device manufacturers after a transitional period of 3 years from April 25, 2020.
When implementing the EU regulation for medical devices, the requirements are based on the already established solution of the FDA UDI and the GUDID database.
However, the final version for the technical details has not yet been published (as of 08.10.2018). Nevertheless, the first framework conditions have already been set as to which data fields and in which structure they are required.
For those persons who have already gained initial experience with GUDID, the EUDAMED data fields will appear to be partly familiar. Here, too, there is a device identifier, manufacturer information, risk class, direct marking, clinical sizes and other similarities.
One striking difference, however, is that very similar products can be grouped together, for example products that only differ in color. This is represented by the term “BASIC UDI” which represents the product group. As can be seen in Figure 1, the attributes that are identical for all products in the group are entered below.
The attributes of the respective product are then entered in the UDI-DI area.
Abbildung 1: BASIC UDI-DI Daten UDI-DI Attribute der EUDAMED
SAP UDI solution based on FDA UDI/GUDID
Our UDI SAP solution for FDA requirements has already established itself several times with customers. Right from the start, we made sure that the data structures were flexible so that an extension to other authorities could be easily and quickly adapted.
All other transactions for data management and data export can now be flexibly adapted to the new EUDAMED fields.
The final version of the EUDAMED solution will be completed as soon as the EU publishes the detailed specification.
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