Benefits of the Data Model

The MDKU data model will be published free of charge in order to support the industry.

Standardize language

Through the unambiguous description of regulatory terms, intended for creation of  clarity as to what is understood by a term or is expected by notified bodies. Today, terms are sometimes defined differently in several regulatory documents, interpreted incorrectly, or used in slightly different ways.

Accelerate digitization

through a uniform data model that can be used by all stakeholders in the MedTech  ecosystem and implemented by all software providers. This also enables consistency and a digital thread between manufacturers, notified bodies, suppliers and other parties.

Goals: efficient creation, review and management of TD

With the unified data model, we can achieve many benefits for manufacturers as well as for Notified Bodies.

MDKU Medical Device Knowledge Units e.V. 

Am Weichselgarten 7

91058 Erlangen