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    Smiling African female pathology technician in blue scrubs preparing test tubes for analysis in Buenos Aires clinical analysis laboratory.
    • Whitepaper
      Medical Devices

    MDR Impact for Combination Products & Substance-Based Devices

    An overview on the implementation of MDR Article 117, Rule 14 and Rule 21.

    Combination products and substance-based devices

    Download the whitepaper to learn more about:

    • Integral Drug-Device Combinations (IDDCs) - MDR Article 117.

    • Drug-Device Combinations - MDR Rule 14.

    • Substance-Based Medical Devices - MDR Rule 21.

    • Borderline cases and classification disputes.

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