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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

    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.

    • Learn when an economic operator becomes a device manufacturer under Article 16/Art 10 obligations.

    • Understand importer/distributor changes and Article 16(4) Certification requirements.

    • Explore conditions for alternative conformity assessment routes for CE Marking compliance.

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

    Speakers

    Hear from these experts in this webinar

    Speaker

    Dr Albert Roossien

    Bert is a Regulatory Lead with BSI since 2017. He is co-responsible for the continued designation as a Medical Devices Notified Body.

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