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    • Webinar
      Medical Devices

    Article 16(4) Certification Scheme requirements

    Article 16(3) of MDR & IVDR describe the requirements for Importers/Distributors who relabel and/or repackage medical devices.

    Watch the Webinar View the Presentation

    Discussing Article 16 MDR/IVDR and BSI’s Article 16(4) Certification Scheme.

    This webinar is open to everyone but will be of most interest to manufacturers, importers, distributors, and other authorized representatives.

    • Gain knowledge and understanding of Article 16.

    • When an economic operator changing products is to be considered the manufacturer of a device.

    • When and under what conditions can an importer / distributor implement changes.

    • Apply for an alternative conformity assessment route leading to Article 16(4) Certification.

    Speakers

    Hear from these experts in this webinar

    Speaker

    Albert Roossien

    Regulatory Lead - NL, BSI

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