IVDR Classification and accreditation

#1
Hello everyone,

I have two question, i will appreciate if anybody response.

1)We are manufacturing "complete cell count device", used for hematology units which is commonly used. And producing diluents. What is the risk class of this device and diluents.

2) In order to do performance study for ivd kit, is it reqired to work with a laboratory which is accredited by national accreditation authority.

Thank again.
 
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