Q
Good Morning Everyone,
Hope all are well. I'm in a debate with my marketing guy and my operations guy over instructions for use and the quantity we need to include in the box.
The product is a prescription only Class II medical device, sold sterile, disposable (single use), individually pouched, 20 pouches to a box. Not CE marked (the CE marked question is later). Currently only 2 IFUs are included in the box.
Contention 1: 2 is adequate, and no more are needed. Doctors know how to use the device.
Contention 2: 2 is not adequate, you don't know the experience level of the user on the other end, and regardless, if we are providing IFUs then the use is not inherently obvious.
The questions is,... are either of these contentions more right than the other, and how many IFUs should/shall be included?
I'm coming up short on guidance from anyone on quantity requirements or recommendations.
Same question then applies to CE marked products. Their IFU is a booklet that has the required translations, but the question of quantity remains the same.
Anyone have any thoughts?
Thansk!
QM Becky
Hope all are well. I'm in a debate with my marketing guy and my operations guy over instructions for use and the quantity we need to include in the box.
The product is a prescription only Class II medical device, sold sterile, disposable (single use), individually pouched, 20 pouches to a box. Not CE marked (the CE marked question is later). Currently only 2 IFUs are included in the box.
Contention 1: 2 is adequate, and no more are needed. Doctors know how to use the device.
Contention 2: 2 is not adequate, you don't know the experience level of the user on the other end, and regardless, if we are providing IFUs then the use is not inherently obvious.
The questions is,... are either of these contentions more right than the other, and how many IFUs should/shall be included?
I'm coming up short on guidance from anyone on quantity requirements or recommendations.
Same question then applies to CE marked products. Their IFU is a booklet that has the required translations, but the question of quantity remains the same.
Anyone have any thoughts?
Thansk!
QM Becky