Search the Elsmar Cove!
**Search ALL of** with DuckDuckGo including content not in the forum - Search results with No ads.

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

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.


Captain Nice
Staff member
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
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, are are you planning to test these products to generate your own data?
Regulatory basis - have you considered the IVDR?
Top Bottom