Labeling for Validation Lots Products

sreenu927

Quite Involved in Discussions
#1
Hi - For IVD products meant for clinical trials in EU, the correct labelling statement is - For IVD Performance Evaluation Only and/or with Test tube with a question mark symbol. And these studies will be registered/notified to the corresponding National Competent Authorities according to the National/Local laws.

Whereas, if the products are meant for validation to be performed at inter company site in EU, not for clinical trials, then what is the labelling statement that we need to use on the products?
Is it okay if we use the same, "for IVD performance evaluation only" wit the corresponding symbol?

Thanks,
Sreenu
 
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sreenu927

Quite Involved in Discussions
#3
Hi Ronen,

Thanks for taking up! As part of the design controls requirements, design validation (diagnostic or clinical validation using patient samples or spooked samples) is performed at sister company site (in EU) away from manufacturing location(ex: Singapore).

Thanks,
Sreenu
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi Ronen,

Thanks for taking up! As part of the design controls requirements, design validation (diagnostic or clinical validation using patient samples or spooked samples) is performed at sister company site (in EU) away from manufacturing location(ex: Singapore).

Thanks,
Sreenu
Hi,

The way I see it, you are not placing anything on the market. Rather, you are purchasing a service from an EC based company (could be at a price of 0). I think your only concern would be ensuring that the shipping packaging and documentation make it ample clear that these are samples intended for lab testing (or the like) and not for use.

Cheers,
Ronen.
 

sreenu927

Quite Involved in Discussions
#5
Hi Ronen - Yes, our concern is
- if we ship the products (to EU -our sister company or a 3rd party) for validation, the products will not have the CE marking and as the validation is not completed (by that time, so IVD symbol can;t be placed), so what is the labelling statement that we can place on the label?
If we place, "For IVD Performance Evaluation Only", it is understood that we need to register with (some) National Competent Authorities.

Is that acceptable to label such products with the same "For IVD Performance Evaluation Only"? (and not registering with any CA!)
How does the CA interpret this labelling statement?

Regards,
Sreenu
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Why should you label them at all? These are samples that go there to be tested - that's all you have to clarify.
 
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