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 […]
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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 […]
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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 […]
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EU AI Act: Transition Period for GPAI Models Placed on Market Before 2 August 2025 Ends Today
As of today, under the AI Act Article 113(3), providers of General Purpose AI (GPAI) models placed on the market […]
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Sign Agreement with Notified Body: Class A Sterile and Class B IVDs
Manufacturers with IVDD legacy devices up-classed to Class A Sterile and Class B must have a signed written agreement with […]
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IVDD Legacy Device Transition Period Ends: 98/79/EC Notified Body Certified and Class D
IVDD legacy devices which were up-classed to Class D under the IVDR, and legacy devices with IVDD 98/79/EC Notified Body […]
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MDD Legacy Device Transition Period Ends: Class III, IIb implantable
MDD legacy devices that are Class III or Class IIb implantable* under the MDR are no longer recognized. To continue […]
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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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MDD/AIMDD CE Marked Devices No Longer Accepted in Great Britain
The device must either be MDR CE Marked or UKCA Marked to continue being placed on the Great Britain (England, […]