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MDR

MDR Classification Mastery

Master all 22 classification rules in MDR Annex VIII. Learn to classify any medical device by understanding the logic behind each rule.

  1. 1

    Classification Principles

    The philosophy behind risk-based classification and how Annex VIII is structured.

    10 minRequires: Scope and Key Definitions
  2. 2

    Non-Invasive Device Rules (1–4)

    Rules governing devices that do not penetrate the body.

    15 minRequires: Classification Principles
  3. 3

    Invasive Device Rules (5–8)

    Rules for surgically invasive and body-orifice devices.

    15 minRequires: Classification Principles
  4. 4

    Active Device Rules (9–13)

    Rules for devices powered by electricity or other energy sources.

    15 minRequires: Classification Principles
  5. 5

    Special Rules (14–22)

    Rules for software, nanomaterials, substances, and other special cases.

    18 minRequires: Classification Principles
  6. 6

    Classification Scenarios Workshop

    Practice classifying real-world devices using the rules you have learned.

    20 minRequires: Non-Invasive Device Rules (1–4), Invasive Device Rules (5–8), Active Device Rules (9–13), Special Rules (14–22)