Blood Bag Classification - with Disposable Centrifugal Unit for processing blood

B

Bassman84

#1
Dear Forum,

I am facing yet another classification issue! I hope that you can help.

With a centrifuge device, if my manufacturer provides a disposable centrifugation unit for the processing of the blood is this classed as a Class IIb device (i.e. a "blood bag"). I was visited by a consultant who says that the whole system is a Class IIb because of the "blood bag" component. Though I do not think that this is the case - I claim that its not a "blood bag", I want to stick with my original Class IIa classification.

Any thoughts on which classification I should stick to?

Thanks.
 
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c.mitch

Quite Involved in Discussions
#3
IMHO rule 3 of the directive seems to cover your case.
However, it's difficult to make one's opinion on a forum.
Maybe you could have look at the most recent version of the "MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES" (google the title, I don't have the link). They have many cases described and solved. It may give you elements to argue.

Regards.
 
B

Bassman84

#4
Thanks for the tips.
I looked through rule 3 and it seems to be classified in accordance with that : A IIa device.

The reason for my uncertainty was that (firstly I am new to this) a consultant on reg affairs visit our company and flippantly said that the centrifuge blood component is a "blood bag". alarm bells, fury from management at my misjudgement - but I calmly told them that this centrifuge bag is not a blood bag.

Cracking... Im going with the IIa classification.
Thanks for your help!

Furthermore, the consultant claims that we should go via Annex II, full quality assurance. My company is a small innovative firm with no quality infrastructure at all. So I need to make it from scratch, I was hoping to go via Annex V and VII (production quality assurance). This would be easier for the company.
I cant help but think that the consultant has an element of self interest at heart here...
 
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