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In-vitro-Diagnostic Medical Device Regulation (IVDR)

    Our newcomers' approach is suited to SMEs, start-ups, and manufacturers dealing with new regulations.

    • Tailored on-boarding package addressing new regulatory aspects​
    • Extra clarification as needed addressing the novel regulatory aspects and DEKRA processes​
    • Regulatory and clinical protocol review to address the critical aspects in an early stage

    Get IVDR Certified With DEKRA

    Reach out to DEKRA today and take the first step towards IVDR marking for your IVD products.
    Important documents and more information about DEKRA Certification B​.V​. (Notified Body 0344)
    FAQs
    Is DEKRA Certification B.V. authorized to provide conformity assessment under IVDR to enable CE marking of the device?
    Do I need both CE IVDR conformity assessment and ISO 13485 certification?
    Should I start conformity assessment for IVDR and ISO 13485 certification at the same time?