Changes and Related Reflections on the European Union's in Vitro Diagnostic Medical Device Classification Supervision System / 中国医疗器械杂志

ABSTRACT

By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR, old IVDD and related guidance documents, concepts of related regulatory reforms were analyzed and explored, to provide references for industrial personnel to understand and master the new EU IVD classification system, and for China's ongoing classification management reform.