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MDCG 2019-13 MDR lla类 Ilb类和IVDR B类 C类器械取样指南，用于技术文件的评估.pdfVIP

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  • 2023-10-11 发布于陕西
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MDCG 2019-13 MDR lla类 Ilb类和IVDR B类 C类器械取样指南，用于技术文件的评估.pdf

    Medical Device Medical Device Coordination Group Document MDCG 2019-13 MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation December 2019 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the

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