nothing but expenses?
The Commission adopted a proposal on Jan. 6, 2023, to provide more time for medical device certification to reduce the risk of bottlenecks. The proposal…
Change of Notified Body
All European Notified Bodies for medical devices lost their designation when MDR and IVDR came into force due to the change in the legal framework…
Increased need for action due to the newly created legal framework for medical devices
As already sufficiently discussed the EU regulation for medical devices is clear is more comprehensive and detailed than the previous Directives. We gladly accept this…