MDR requirement where unit of use packaging is too small for UDI carrier

Awadine

Involved In Discussions
#1
Hi

Hopefully not a silly question - I am unclear on what the MDR requirement is where an individual device is too small to be labelled with a UDI carrier.

We make small sterile products provided in individual sterile packaging (approx 1cm x1cm x1cm) which are then placed in shelf boxes of 50, 100 etc units. The unit of use product is too small to add a UDI carrier on. So the UDI carrier must go on the shelf box. But:

We have Annex VI Part C point 3.1:
”A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI”

Then Annex VI Part C point 4.2 states:
In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher level of packaging

So, does that mean that a UDI-DI must still be assigned at unit of use level even if there is no space to place a UDI carrier at unit of use level and the shelf box must then display the unit of use UDI carrier AND the shelf box (multi-unit) UDI carrier?

Or, does the shelf box just need to display one UDI carrier relating to the multi unit product (i.e. 50, 100 etc units not an individual unit).

If anyone can clarify or point me to some guidance, I would be really grateful.
 
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Sinus Tarsi

Involved In Discussions
#2
Same here. Our sterile device is placed in a pouch and then in a shelf box. Each shelf box contains ONE STERILE DEVICE. The UDI-DI, as well as all the other required information, is on the outer individual shelf box label. Even though the device is very small, we had to package them individually because of this.
 
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