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    • Brochure
      Medical Devices

    Article 16(4) Certification Medical Devices and IVDs

    Relabelling or repackaging activities under MDR/IVDR.

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    Article 16(4) Certification Medical Devices and IVDs FAQs

    These guidelines include:

    • Article 16(4) Certification Process.

    • Article 16(4) responsibilities and activities.

    • BSI Article 16(4) Certification.

    • Guidance on field examples.

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