With the update of the directives to regulations for both medical devices and in-vitro diagnostics, an update of the EUDAMED database became inevitable.
The database will be the single repository for data on medical devices and in-vitro diagnostics marketed in the EU/EEA/EFTA to publicly access safety and performance data along to the economic operators and Notified Bodies involved in the market clearance and surveillance of every specific product.
The European Commission further envisions a more transparent and congruent data collection over all medical devices and in-vitro diagnostics in its market. This should allow not only to identify easily the actors and responsible but also to monitor the safety and performance of products over time.