MedicalDevice
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Hi everyone.
I hope you are well and healthy!
Could you please provide me with any information regarding what's needed to do a self-certification for a CE mark on a class I device (face mask)?
I have checked with our NB and was told that a self-assessment can be done by us for the face mask.
Also, is the self-certification applicable for a class I sterile medical device?
Appreciate all the help!
I hope you are well and healthy!
Could you please provide me with any information regarding what's needed to do a self-certification for a CE mark on a class I device (face mask)?
I have checked with our NB and was told that a self-assessment can be done by us for the face mask.
Also, is the self-certification applicable for a class I sterile medical device?
Appreciate all the help!