M2M Data Exchange available services for accessing MDR EUDAMED data available for Economic Operator (EO) organisations
Posts published in “In Vitro Diagnostic Medical Device Regulation IVDR”
Corrigenda for MDR and IVDR published in Official Journal
EUDAMED UDI Device Data Dictionary MDR – UDI and device data sets to provide in EUDAMED IVDR – UDI and device data sets to provide…
State-of-play of joint assessments of Notified Bodies in the medical device sector
15418/1/18 REV 1 – Corrigendum for the EU IVDR
Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited
First guidance on new rules for certain medical devices
MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers
In several EU languages – Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics
Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices