How to Classify Your Medical Device Under the EU MDR and IVDR
Arena Solutions
AUGUST 7, 2023
wheelchair, hospital bed) Class Is: Delivered sterile; must be either transported in a sterile condition or sterilized upon receipt (e.g., Refer to guidance documents published by the Medical Device Coordination Group (MDCG). The MDCG documents also present practical examples of how the rules would apply to various devices.
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