Welcome to our site. Here you will get the latest News and information in the future.
Stay connected.
Dr. Gerold Labek, European Arthroplasty Register Network medical
Welcome to our site. Here you will get the latest News and information in the future.
Stay connected.
The Medical Device Regulation (MDR) will be enforced at 26th May 2021.
One aspect of the radical change in requirements concerning clinical data and evidence is, that register data have to be considered by manufacturers as a mandatory part of their clinical evaluation on their devices (i.e. structured presentation of evidence concerning safety and performance of their devices).
The definition of „register“ by the International Medical Device Regulators Forum IMDRF is wider as the one used in academia and refers to any structured data collection without defined termination.
Existing register projects have some advantages concerning these requirements and the present situation. This refers for example to: