Reply To: Definition of “clinical investigation”

  • Amie

    Member
    September 2, 2025 at 12:16 pm

    Yes, for legacy devices, per MDCG 2023-7, a clinical investigation is not required providing there is “sufficient clinical data” – and that can be clinical data from any of the sources listed in Article 2(48), including equivalence (no contract required for legacy devices).

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