IVDR CE Mark for Class A products - Declaration of Conformity

#1
Does "Declaration of Conformity" for Class A product need to be submitted to Notified Body (NB) before placing the CE mark? In other words, does the company need NB approval before placing Class A IVD product in the EU?
 
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chris1price

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#2
I suggest reading the IVD Directive carefully, in particular, for Class A products Article 9 and Annex IV and V.

Yes, the company required NB approval before placing class A products on the EU Market. The usual sequence is prepare your technical/quality files, including a draft DoC. Submit them to the NB for approval, once approval is received, you then finalise the DoC and can start selling.
 
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