Electrical Medical Devices class I

drwallice

Registered
Dear all,
I would like to ask you kindly for you opinion in this matter.
I don't have experience in the Electrical Medical Devices class I. We are a contract manufacturer for this devices. My question is under MDR what is the speical requirements and testS for this category besides the main requirements ( like: CER, BioC, GSPR and RA).
Thank you for your time and effort.
 
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