Performance evaluation data can derive from performance studies. Data generated in performance studies must be reliable and robust, as stated in the Regulation on IVD…
MDCG templates for performance study application and PMPF study notification
In December 2022, the Medical Device Coordination Group published various templates on performance study application and PMPF (Post Market Performance Follow-up) study notification. Documents for…
Swissdamed: Database for Medical Devices in Switzerland
In Switzerland, Swissmedic enforces the registration of economic operators and medical devices. For this purpose, Swissmedic introduced a new database: Swissdamed. Swissdamed stands for “Swiss…
Practices and alternatives until EUDAMED is fully functional
The new Regulations on medical devices (MDR) and in vitro medical devices (IVDR) introduced EUDAMED, a new traceability system for medical devices on the EU…
EUDAMED Delayed!
The European Commission has announced a delay of the full functionality of the European database on medical devices (EUDAMED) and a new update of the…
EUDAMED: NB, Certificates & UDI/Device registration – Useful documents
Notified Bodies and Certificates The European Commission has released updated documents on the technical documentation relevant for Notified Bodies and the related registration of certificates…