European Commission · September 07, 2025

HTA Regulation - Medical Devices: Joint Clinical Assessments extended to selected high-risk devices and in-vitro diagnostics

Original title: HTA Regulation - Medical Devices

Joint Clinical Assessments under the HTA Regulation now extend to selected high-risk medical devices and in-vitro diagnostics, expanding scope beyond pharmaceuticals.

High impact Medical Devices Market Access & Reimbursement EU-wide medical-devicesivdhtareimbursement

Joint Clinical Assessments extend to selected high-risk medical devices and in-vitro diagnostics

Dates and deadlines

Enters Force

January 01, 2026

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Published by European Commission. HealthSignal links to the original document; the summary above is extracted from the source text.