Audit in accordance with new Medical Devices Regulation (MDR)

Ready for the future: DeltaMed GmbH was one of the first companies to be audited by its notified body in accordance with the new European Medical Devices Regulation (2017/745)

The new regulation, which will come into force in May 2021, is mandatory for all medical device manufacturers and will replace the current Medical Devices Directive 93/42 EEC.


“Adapting to the new legal requirements and the associated documentation effort presents a challenge for all medical technology companies that should not be underestimated. In order to meet these requirements, we expanded our personnel resources early on and adapted our processes accordingly. The expertise we have obtained as a result of this process means we can now provide expert support to our customers and partners through the transition phase”, says Emanuel Mesaric, Managing Director of DeltaMed GmbH.


Implementing the new regulation involves significant additional effort for medical device manufacturers to meet the stricter regulatory standards.


About DeltaMed

DeltaMed GmbH develops and produces materials for various dental, medical, and technical applications. Core competences include material and process development for additive manufacturing approaches. Other focus areas include the development and production of light-curing materials for restorative dentistry and dental technology.

DeltaMed is part of the Prodways Group, a corporation headquartered in Paris, which offers integrated solutions for the entire 3D printing supply chain, including equipment, materials, processes, and software.