Licence Model

With regard to our intentions, we plan to grant licenses for using the data model to everyone for using in any kind of context. This means: we want the model to be usable by anyone, without collecting fees, giving permission or posing other restrictions on use. However, for legal reasons, and to further strengthen our mission, some license agreement will be needed – which all ouf you should be fairly familiar with from using open source software!


What are our intentions regarding licensing?

“Spreading good things”: We aim for use of the model in as most cases as possible regarding approval of new medical devices, for each interested party and for all kind of purposes within the scope of medical devices and IVDD, especially but not limited to commercial purposes. “Single source of truth”: We want to provide a unified, curated (by MDKU), reliable and widely accepted data base. This means, users are entitled to alter aspects of the data model for their own purposes under their own control and on their own risk, but certainly not change the curated data model. Changing the model means losing the preapproval status and may lead to additional questions frm notified bodies, and will prohibit from calling the resulting data set compliant with the data model. Changes to the published data model are solely to be planned, executed, approved and published by the MDKU as “authoritative representation”, hence anybody is entitled to make a change request as the need arises.

“Community work result”: Any user of the data model shall be obligated to
a) name the original creators of the data model and
b) sharing of the unaltered model is only permitted by accepting the terms of the original license and under the very same license as the original work. This approach is called “copyleft” in the software scope.

Given this, the following license model from the Creative Commons Suite is currently planned to be used:


This license lets others reuse the work for any purpose, including commercially; however, it cannot be shared with others in adapted form, and credit must be provided to you. Please bear in mind that we are still working on legal issues and also still lack a final decision on certain side aspects of this kind of licensing, so this is somewhat of a temporary statement. But we expect to have the remaining questions worked out by the end of the year, and certainly in time for the first release of the model!

MDKU Medical Device Knowledge Units e.V. 

Am Weichselgarten 7

91058 Erlangen