EUDAMED: Use Expected to be Mandatory Q1 2026
The use of the EUDAMED 1) Actor, 2) UDI/Device, 3) Notified Bodies/Certificates, and 4) Market Surveillance modules is expected to […]
10 events found.
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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 […]
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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 […]
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Lodge Application with Notified Body: Class C IVDs
Manufacturers with IVDD legacy devices up-classed to Class C under the IVDR, must have lodged an application with a Notified […]
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Class III Implantable Custom-Made Devices: Extension Period Ends
Class III implantable custom-made devices (CMDs) must comply with the MDR in order to continue being placed on the market, […]
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‘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 […]
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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 […]
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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 […]
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‘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 […]
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EUDAMED: Transition Period Expected to End Today, Making Compliance Mandatory
The use of the EUDAMED 1) Actor, 2) UDI/Device, 3) Notified Bodies/Certificates, and 4) Market Surveillance modules is expected to […]