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    Joint Clinical Assessment

    EU-wide clinical assessment of high-risk medical devices and IVDs.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Under the EU HTA Regulation (EU) 2021/2282, the Joint Clinical Assessment provides a single clinical evaluation across EU member states for selected high-risk devices and IVDs, beginning 2026 for devices, with national pricing and reimbursement decisions remaining country-specific.

    What this means in practice

    Aims to reduce duplicate national clinical assessments. PICO definition, comparator selection, and evidence package are critical.

    Primary references

    3 sources
    Link health: 1 verified 2 needs review· last checked 2026-05-09
    European Commission·1CMS·2
    1. 1
      EU HTA Regulation
      Verified
      European Commissionhealth.ec.europa.eu
    2. 2
      CMS - Coverage
      Needs review
      CMScms.gov
    3. 3
      CMS - Coding
      Needs review
      CMScms.gov

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