After the adoption of the new Medical Device Regulation (MDR) by the European Parliament, many manufacturers and distributors of medical devices have already started to adapt their processes. However, although the implementation period for the MDR ends in 2020, many companies still need information about the effects of the new MDR and how the approval of medical devices will work in the future. This practical workshop closes this information gap and accompanies you step-by-step and through practical examples through the entire process of approval of medical devices.  

On the first day you will learn which regulatory requirements you as a manufacturer or distributor of medical devices have to meet, how the CE marking process works, how to obtain a clinical evaluation and what you need to consider after placing the medical device on the market. The role of the certified bodies and authorities is explained as well as the tasks of internal monitoring.  

The second day focuses on the implementation of the regulatory requirements in the company. Using the example of a specific medical device, you will get to know the new processes from start to finish.

Program .pdf download here please >>