Class 2a CE Mark Regulatory Pathway

A

asantcom

AS345
#1
#1
I am working on a new product that is a class 1s device and we are seeking CE mark. What are the available regulatory pathways and involvement of the NB?
 
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C

cfcruz

Starting to get Involved
#2
#2
Involvement of the NB for a class Is is limited to the aspects of manufacture concerned with securing and maintaining sterile conditions. The MDCG 2019-15 provides guidance in the conformity assessments for class I, including class Is.
 
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