May 27, 2021 /
— 5:00 pm
In May 2021, the new EU Medical Device Regulation (MDR) will come into force. Expert Prof. Dr. Christoph Russmann explains what this regulation means for your start-up.
The MDR defines the requirements that a manufacturer must meet in order to sell medical devices in Europe. Among other things, the regulation specifies the requirements for clinical evaluation, regulates the reprocessing of single-use devices, including the ban on reprocessing certain single-use devices, as well as the new classification rules for software, products with nanomaterials, and so-called material medical devices, among others. Mr. Russmann will try to "translate" the innovations of the directive for you.
The aim of the event is that you get to know the new regulation and what it means for your specific case. We will therefore pick out individual passages of the regulation text and explain on the basis of these examples which requirements you must pay attention to for your products in the future. You will also have the opportunity to ask your questions.
About the speaker:
Prof. Dr. Christoph Russmann is Dean Health at the Health Campus Göttingen and Professor for Photonics and Medical Technology. In his function as professor at HAWK, he is in constant exchange with young innovators who already set the user focus in their academic education. Christoph Russmann is thus sensitized to the impact of a new medical device regulation on the development of MedTech start-ups. This makes him an ideal contact person for questions concerning the approval of medical devices.
We look forward to a lively interactive exchange, new food for thought and, above all, helpful information on the new Medical Device Regulation.