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The 2025 Work Programme for the new joint EU-level HTA framework (HTAR) released
On December 3, 2024, the Member State Coordination Group on HTA released the 2025 Annual Work Programme for the new joint EU-level HTA framework (Regulation on Health Technology Assessment, HTAR). The framework will be fully operational from January 12, 2025.
The EU Regulation on Health Technology Assessment (2021/2282) came into force on January 11, 2022. During the preparatory phase for HTAR implementation, the Coordination Group on HTA (HTACG) was established, consisting of representatives from Member States, primarily from HTA authorities and bodies. The HTACG’s main responsibilities include coordinating and adopting joint HTA work conducted by its sub-groups within the HTAR framework.
For medical devices, the following sub-groups have been established:
- Joint Clinical Assessments (JCA);
- Joint Scientific Consultations (JSC);
- Identification of Emerging Health Technologies (EHT);
- Development of Methodological and Procedural Guidance.
The 2025 Work Programme outlines these plans related to medical devices:
- Joint work on medical devices will begin with joint scientific consultations (JSCs);
- Medical device manufacturers will be invited to submit JSC requests in the second half of 2025;
- The HTACG plans to initiate 1–3 JSCs for medical devices in 2025, with a gradual increase in offerings in subsequent years;
- No joint clinical assessments (JCAs) for medical devices will be conducted in 2025. The HTACG will focus on collaborating with Member States to develop JCA procedures for medical devices.
Detailed instructions for submitting JSC requests via the HTA IT Platform will be published by the HTA Secretariat in due course.
See more details here and here.
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