• Search BSI
  • Verify a Certificate
BSI Home page
Contact Us
Search Icon
Back to menu Choose a country/region

No countries/regions found

Suggested region and language based on your location

    Your current region and language

    Submit
    3 doctors having a discussion
    • 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

    Insights & Media

    Find out about the latest quality trends with insights from our experts

    Get Insights & Media
    Contact Us

    Let's shape your organization's future together

    Reach out and see how we can help guide you on your path to sustainable operational success.

    Get in touch
    Get in touch