• ค้นหา BSI
  • ตรวจสอบใบรับรอง
หน้าหลักของ BSI
ติดต่อเรา
Search Icon
กลับไปที่เมนู เลือกประเทศ/ภูมิภาค

ไม่พบประเทศ/ภูมิภาค

Suggested region and language based on your location

    Your current region and language

    Submit
    doctor and patient on walker
    • Whitepaper
      Medical Devices

    Annex XVI - Devices Without an Intended Medical Purpose

    Learn more about Annex XVI regulatory framework and devices without an intended medical purpose.

    Read the document

    In this document:

    • Qualification and classification.

    • Borderline products and the applicability of other EU legislation.

    • Claiming equivalence and Clinical Evaluation Consultation Procedure.

    • References and guidance.

    Insights & Media

    Learn from global experts in healthcare standards

    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