‘swissdamed’ Device Registration Module: Scheduled to Go Live Today
The update from Swissmedic is available: HERE Background Swissdamed is made up of two modules (Actors & Devices) and is being […]
10 events found.
Events
-
-
-
-
EU AI Act: Rest of Act Now Applies (except Article 6(1)), Including for High-Risk AI Systems
Per Article 111(2), the AI Act shall apply to operators of high-risk AI systems: Systems placed on the market before […]
-
-
Sign Agreement with Notified Body: Class C IVDs
Manufacturers with IVDD legacy devices up-classed to Class C under the IVDR, must have a signed written agreement with a […]
-
-
EUDAMED Device Registration Transition Period Ends
Use of the EUDAMED Actor and UDI/Device modules is now mandatory for all devices on the market. Background: The use […]
-
-
‘swissdamed’ Device Registration Module: Transition Period Scheduled to End Today
The update from Swissmedic is available: HERE Registration in the Devices module will become mandatory as of 1 July 2026, followed […]
-
-
Annual EMDN Code Revision: Monitor for Published Changes
EMDN codes are subject to change. Each year, the Commission publishes a list of all codes that have been newly […]
-
-
IMDRF Adverse Event Report (AER) Terms and Codes Updated
The IMDRF reviews AER revision requests annually and updates the codes as needed. The process to request code revisions is […]
-
-
UDI Carrier: Class A IVDs
UDI carrier required on Class A IVD device labeling. This is outlined in the IVDR: Article 113(e) establishes that Article […]
-
UDI Direct Marking: MDR Class I reusable devices
UDI Direct Marking is now required for MDR CE Marked Class I reusable devices. This is outlined in the MDR […]
-
Lodge Application with Notified Body: Class A Sterile and Class B IVDs
Manufacturers with IVDD legacy devices up-classed to Class A sterile or Class B under the IVDR, must have lodged an […]