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    • 01 ES 🇪🇸 regulations
    • 02 US 🇺🇸 CFR FDA
    • 03_Clinical studies
    • 04 EU 🇪🇺 Medical devices
      • 04_01_2007_MDD 93_42_EEC
      • 04_02_2017_745-MDR_20200424_EN
      • 04_03_2017_2185 MD coding
      • 04_04_2023_607_MDR & IVDR transition approval
      • 04_05_2012_207_en_Electronic IFU
      • 04_06_2021_2226_en_Electronic IFU
      • Guides
        • 04_G01_MD_borderline_manual_05_2019_en_0
        • 04_G02_MD_borderline_manual_12-2022_en
        • 04_G03_MedDev 2 12-1_rev8_en_Vigilance system
        • 04_G04_MDCG_2020_5_guidance_clinical_evaluation_equivalence_en_0
        • 04_G05_MDCG_2020_7_guidance_pmcf_plan_template_en_0
        • 04_G06_MDCG_2020_8_guidance_pmcf_evaluation_report_en_0
        • 04_G07_MDCG 2020-1 Clinical Evaluation MDSW
        • 04_G08_MDCG 2022-4 Rev.1 Transitional Provisions_changes
        • 04_G09_MDCG_2022-21_en_PSUR
        • 04_G10_MDCG_Q&A Vigilance_2023-3_en_0
        • 04_G11_MEDDEV_2_1_6_072016_en
        • 04_G12_MedDev_2_7_1_rev4_en Clinical Evaluation
        • 04_G13_2023 C 163 06_Summary of the CIR
        • 04_G14_MDGC_Transitional provision under article 120_2020-3_en
        • 04_G15_Manual on borderline and classification for medical devices
        • 04_G16_Principles and Practices for Medical Device Cybersecurity
        • 04_G17_IMDRF Machine learning enabled Medical devices:Key terms and definitions
    • 05_GP-004 Vigilance system
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  • External documentation
  • 04 EU 🇪🇺 Medical devices
  • Guides
  • 04_G02_MD_borderline_manual_12-2022_en

04_G02_MD_borderline_manual_12-2022_en

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