How to Classify Your Medical Device Under the EU MDR and IVDR
Arena Solutions
AUGUST 7, 2023
Under these new regulations, the definitions of medical and in vitro diagnostic devices have been expanded. EU MDR – Annex VIII EU IVDR – Annex VIII Annex VIII provides definitions that are specific to the classification rules (e.g., Additionally, certain devices have been reclassified to higher or new risk categories.
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