Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the…
Business associations’ letter on EUDAMED mandatory use
Six industry associations on medical devices and healthcare have jointly signed an open letter on…
EUDAMED delay announced!
The European Commission has officially announced a delay in the full implementation of the EUDAMED…
Guidance on EAR: obligations and responsibilities under the Regulations
In October 2022, the Medical Device Coordination Group (MDCG) published a new Guidance on obligations…
Swissdamed: Database for Medical Devices in Switzerland
In Switzerland, Swissmedic enforces the registration of economic operators and medical devices. For this purpose,…
Practices and alternatives until EUDAMED is fully functional
The new Regulations on medical devices (MDR) and in vitro medical devices (IVDR) introduced EUDAMED,…
EUDAMED Delayed!
The European Commission has announced a delay of the full functionality of the European database…