Hi hoping someone can help me out with this -
We have determined that we are a Class 1 (non-sterile. non-measuring, non-resuable) device under the MDR. We have finished all required documentation. We have finished our Declaration of Conformity and are wondering for self certification:
Do we send the Declaration of Conformity to our Competent Authority (like under the MDD)? Or, do we send the Declaration of Conformity to a Notified Body?
We have determined that we are a Class 1 (non-sterile. non-measuring, non-resuable) device under the MDR. We have finished all required documentation. We have finished our Declaration of Conformity and are wondering for self certification:
Do we send the Declaration of Conformity to our Competent Authority (like under the MDD)? Or, do we send the Declaration of Conformity to a Notified Body?