We – the experts in our industry – are convinced that we have to change the way how we created and maintain information related to medical devices. And the basis for a more efficient information management and digitalization is standardization of the language that we use every day in the documentation.

In 2019, none of the existing regulatory organizations were working on a such an concept and therefore we decided: We, the MedTech community, have to develop such a data model by ourselves. From the community, for the community. And the idea of a MDKU was developed.

We are not commissioned by any national authority, notified body, industry association or company. But we are supported by many stakeholder in the ecosystem that share our vision: a simplified regulatory framework through a clear language of used terms.

It is important for us that no commercial interests are pursued and that the data model is made available as easy as possible for all stakeholders in the industry in order to ensure broad application. In other words, no software will be developed for the application of the MDKU data model, but it will be ensured that the data model can be used by all common software solutions for the digitization of regulatory processes.