Classification of Waste Bag Needed?

[nishu92]

I am looking at the classification of a waste bag that holds the waste solution, including plasma, cellular components, and saline solution washed out of the red cells during processing. It is considered a Class II (US) and Class IIa (EU) when packaged as part of the processing set. The problem is it is also classified as a Class II or Class IIa, when used as a standalone product, which isn't accurate. I believe it would be Class I device, as the waste bag collects liquid waste from the processing set and it is not reinfused.

Would this be correct for both FDA and EU classification?

Could I also say this follows 21CFR880.6730?

Looking to understand if my classification is correct.

 

[Ed Panek]

Does it have a performance specification?

 

[nishu92]

This bag is sterilized and has performance specifications. Looking to classify it as a standalone device, instead of as part of kit or set.

Does it have a performance specification?

 

[ParisTommy]

Hello,

for the EU classification, according to MDCG 2021-24, rule 1 would seem to be appropriate.

"as the waste bag collects liquid waste from the processing set and it is not reinfused."