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  • Quality Manual
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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
    • 05_GP-004 Vigilance system
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    • 09 Pharmacy
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    • 11 UK 🇬🇧 Medical devices
    • 12 EU 🇪🇺 AI Act
  • External documentation
  • 04 EU 🇪🇺 Medical devices

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

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