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:
- They have already established an infrastructure and collect data on a regular base. So they are able to provide data and evidence in short term.
- They perform data collection and evaluations based on processes independent from stakeholders involved in the assessment for market approval. Consequently a higher level ot transparency and independence and limited risk for bias can be presumed. Regulators have defined expectations on register data used in their processes by IMDRF.
EARN is acting proactively to implement these expectations into cooperating registries and increase the value of their data delivered to processes concerning market approval and market monitoring.