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 […]
10 events found.
Legacy Devices (MDD/AIMDD/IVDD)
Events
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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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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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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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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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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, […]
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IVDD Legacy Device Transition Period Ends: Class C
IVDD legacy devices which were up-classed to Class C under the IVDR are no longer recognized. To continue placing these […]
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MDD Legacy Device Transition Period Ends: Class IIb non-implantable, Class IIa, and Class I
MDD legacy devices that are Class I, IIa, or IIb non-implantable* under the MDR are no longer recognized. To continue […]