Joint Clinical Assessments Medical Devices

Illustration of Joint Clinical Assessment (JCA) for medical devices in the European Union. The image shows EU stars, an assessment checklist, a monitor displaying health data, and a knee implant. The graphic represents the Europe-wide clinical assessment of medical devices to support consistent healthcare decision-making across EU member states.

Project Lead: Judit Erdös
Authors: Judit Erdös, NN
Duration: fromQ4 2026 (ongoing)
Language: English

Since January 2025, the implementation of the HTA Regulation (HTA-VO) has been mandatory. Starting in January 2026, the clinical added benefit of selected high-risk medical devices must be evaluated through joint European assessments (Joint Clinical Assessments/JCA).

AIHTA is planning to conduct JCAs for medical devices.

Project Short Description