Suggested region and language based on your location

    Your current region and language

    medical syringe
    • Brochure
      Medical Devices

    BSI MDR Annex XVI Q&A

    Questions and Answers for Products without an intended medical purpose.

    In this document:

    • What products are covered by Annex XVI.

    • Transitional provisions & CECP.

    • Lead times.

    • Dual purpose products.

    Contact Us

    Let's shape your organization's future together - BSI Akamai Changes

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

    Get in touch