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    Two employees of CLASSYS holding certification.
    • Case Study
      Medical Devices

    CLASSYS secures first MDR certification for Annex XVI devices

    With BSI, CLASSYS achieved CE certification under the MDR for Ultraformer MPT and Volnewmer, supporting European market access.

    Annex XVI Whitepaper
    Testimonial

    “Structured Dialogue combined with rigorous and constructive auditor engagement streamlined our technical documentation review.” 

    Giho Kang Chief Regulatory/Quality/Clinical Officer, CLASSYS Inc.
    Female dermatologist doctor in her office at a dermatology and aesthetic clinic.
    The Client

    About CLASSYS

    Founded in 2007, CLASSYS is a Korean global aesthetics manufacturer.

    They provide advanced HIFU, radiofrequency & laser systems to more than 80 countries. Its mission is to democratize aesthetic procedures through customer centric innovation.

    The Challenge

    Building confidence through MDR regulatory change

    CLASSYS needed to navigate new Annex XVI requirements for non-medical aesthetic devices, with limited market precedents available.

    CLASSYS faced regulatory uncertainty during the transition from MDD to MDR, particularly for Annex XVI non-medical aesthetic devices such as HIFU and RF systems. With limited precedents available, the organization needed to demonstrate strengthened clinical evidence and post-market surveillance activity. CLASSYS sought a Notified Body with trusted expertise, structure and consistency to support a robust conformity assessment pathway and help the company enter key European markets with confidence.

    The Solution

    A structured conformity assessment pathway

    BSI provided a timely, organized review process, combining Structured Dialogue with rigorous technical documentation assessment.

    CLASSYS obtained CE certification under the MDR for Ultraformer MPT and Volnewmer, securing the first market authorization for these Annex XVI aesthetic devices in Europe. BSI supported the conformity assessment through a structured review process, clear coordination and timely feedback at each stage. The approach helped CLASSYS proceed with a robust CE MDR submission while maintaining visibility of review milestones and requirements.

    The Benefits

    MDR certification reinforced CLASSYS’ global credibility and created a stronger foundation for European growth.

    Group photo CLASSYS employees.
    • Icon description

      First MDR certification for Annex XVI HIFU and RF devices.

    • Icon description

      Strengthened worldwide trust in product safety and performance.

    • Icon description

      Supported confident entry into key European aesthetic markets.

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      Built a robust foundation for future portfolio and market expansion.

    Business colleagues discussing in the meeting room.
    Why BSI

    CLASSYS selected BSI for its medical devices certification experience, Annex XVI knowledge and rigorous assessment standards.

    BSI’s structured engagement, established MDR expertise and consistent review coordination supported CLASSYS through a complex conformity assessment pathway while maintaining impartiality and assessment rigour.

    Contact Us

    Let us help you on your certification journey

    Explore BSI medical devices certification and MDR conformity assessment services. Contact BSI to discuss your conformity assessment requirements.

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