유럽 MDR, IVDR

[MDCG 2020-3] Guidance on significant changes regarding the transitional provision under Article 120

MD우야 2023. 9. 27. 09:00
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▶ 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

 

 

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