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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.

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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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