Medical devices must be safe, perform well and be useful. To prove this, clinical evaluations are required.
The requirements for such evaluations have increased significantly with the introduction of the European Medical Device Regulation (MDR). In particular, the ability of manufacturers to use clinical data from other medical devices (equivalence data) has been severely restricted. As a consequence, manufacturers have to generate clinical data of their medical devices themselves at high financial and time costs. In addition, the MDR increases the requirements for clinical follow-up. The clinical evaluation of a medical device does not end when it is made available on the market. Clinical evaluations may also be required during marketing.
On January 27, 2021, our experts will show you which changes have occurred as a result of the MDR for a clinical evaluation, how tools can support the process, and how clinical follow-up (PMCF) can be implemented in an MDR-compliant manner.
Please note that this event will be held entirely in German.