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Re-labelling in IVDD - Re-label two products and package them as one

#1
Hi
My company is thinking of building a IVDD reagents combining two products from other company.
Our idea is re-label two products and package them as one with our brand and label.
My question is can we use two products stability data in our re-labelled product?
If so what do need to cover the regulatory basis?

Thank you.
 

Marc

Captain Nice
Staff member
Admin
#3
Yes - Hopefully someone with medical device experience will help out, but as it goes in forums, sometimes no one spots it. Please understand people who do help out here do so without compensation so there are no guarantees.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
I'm not really from the IVD world (more non-IVD MD) but I'll try to help anyway.
Clarification questions:
- Do you intend to keep the two products from the other company packaged separately, or mix them and sell as a single substance?
- If keeping packaged separately, are you going to relabel the individual products, or to keep the original labelling and just package together in/under/with your own labelling?
Do you have access to the original stability data, or are you planning to test these products to generate your own data?
Regulatory basis - have you considered the IVDR?
R.
 
Last edited:
#5
Thank you for the reply Ronen.
We have not considered IVDR yet.
There is no mixing involved. Just two different components used in one process.
Originally, we were thinking of re-labelling each component and put in one box, but from the question your asking there looks like a difference in regulatory perspective.
We do have stability data for one component but not for the other, so we are thinking of generating our own data.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#6
Given the no-mixing and re-labeling you will most likely need stability data for each.

If you're located in the EU or are planning to sell in the EU, you should look into the IVDR. That will give you detailed, more complete and authoritative answers.
 
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