Thanks for the great video, would you please help me understand as when would be the deadline/ time for the UDI code for a new medical device to be applied on the packages. The medical device is being manufactured, already certified under MDR by the notified body.
Can you explain an example with quantity of one? Let's say a tube gets UDI-DI, it will go as a single unit into the package, which will be sold like that. Does the package get the same UDI-DI as the one on the tube or are they different?
Hi Sarah, Thanks for asking. The UDI will be the same on the tube and the package (as long as there is only one device in the package). But if you start to sell the tube 5 by 5 in a bigger package then that 5pcs package will get a new UDI (but same Basic UDI-DI)
Thank you for the clarifying video (The names and abbriviations almost look to be thought up by someone who wanted to be as confusing as possible!). I think there are some links you mentioned were to be found below the video that don't seem to have ended up there. Could you maybe add them?
@@MedicalDeviceHQ True. When I started working with medical device regulations the first thing I did was make a list of abbrevations (apptly named 'LoA' of course). Sadly it's quite a long list.
Thanks for the great video, would you please help me understand as when would be the deadline/ time for the UDI code for a new medical device to be applied on the packages. The medical device is being manufactured, already certified under MDR by the notified body.
Can you explain an example with quantity of one? Let's say a tube gets UDI-DI, it will go as a single unit into the package, which will be sold like that. Does the package get the same UDI-DI as the one on the tube or are they different?
Hi Sarah,
Thanks for asking. The UDI will be the same on the tube and the package (as long as there is only one device in the package). But if you start to sell the tube 5 by 5 in a bigger package then that 5pcs package will get a new UDI (but same Basic UDI-DI)
Thank you for the clarifying video (The names and abbriviations almost look to be thought up by someone who wanted to be as confusing as possible!). I think there are some links you mentioned were to be found below the video that don't seem to have ended up there. Could you maybe add them?
They are indeed very confusing. Actually I think the UDI abbreviations are a bit worse than the DHF, DMR and DHR :-)
@@MedicalDeviceHQ True. When I started working with medical device regulations the first thing I did was make a list of abbrevations (apptly named 'LoA' of course). Sadly it's quite a long list.