IVD Collection Ki

MarRz

Involved In Discussions
Hello. We buy a Class A sterile device and get it in a pack of 50 pieces. We ship them individually in our own box and want to sell that box as IVD Collection kit, so that we can put a CE mark on it (and other relevant medical device data from the Class A sterile device that is inside).

I have no experience with making IVD collection kit before, so I would appreciate all suggestions how to proceed. Some of the questions:
  • Can we proceed without NB, and mark the Collection kit as Class A, even though there is a Class A sterile device inside, that required NB for registration (all already done by manufacturer that sells that device to us)?
  • After preparing the label, we issue a Declaration of Conformity for our IVD Collection pack?
  • I assume we have to register IVD Collection pack as medical device with local authority?
  • Can the non-medical content of the IVD collection pack (paper, bubble wrap) change later on without a problem, or do we have to do something, when making changes (e.g. Issue a new DoC)?
 
The classification of your product is based on its intended purpose and associated risks. You have not told us anything about the intended use.
 

MarRz

Involved In Discussions
The intended purpose of the IVD Collection Kit is to enable the collection of maternal blood samples (with the help of the medical device that is part of the package) and later on preserve (rigid box for transport and gel pack to prevent quick changes in the temperature) and transport them.
 

MarRz

Involved In Discussions
I found that IVDR says the Kit is a medical device and must be registered. For that we need technical documentation. But I am not sure what to prepare and if we can omit parts of technical documentation; e.g. it makes sense to do risk file, but with regards to the performance evaluation, I don't see how we could do scientific validity, analytical performance, etc. for the collection kit a.k.a. "box".

Any suggestions on that?
 
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