[MDCG 2020-3] Guidance on significant changes regarding the transitional provision under Article 120 ▶ MDCG 2020-3 문서가 'Regulation 2023/607'과 'MDCG 2022-2' 문서에 맞게 전체적으로 개정 되었음 ▶ Significant change - intended purpose - design - software - substance or materials - sterilization 유럽 MDR, IVDR 2023.09.27