Class 2a CE Mark Regulatory Pathway

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?


Starting to get Involved
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.
Top Bottom