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    • Whitepaper
      Medical Devices

    Annex XVI - Devices Without an Intended Medical Purpose

    Learn more about Annex XVI regulatory framework and devices without an intended medical purpose.

    Download the Document

    In this document:

    • Qualification and classification.

    • Borderline products and the applicability of other EU legislation.

    • Claiming equivalence and Clinical Evaluation Consultation Procedure.

    • References and guidance.

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