EU JCA

On November 28, 2025, the Member State Coordination Group on Health Technology Assessment (HTACG) published its annual Work Programme for 2026, outlining the priorities and activities within the joint EU-level HTA framework (EU HTAR). In 2026, HTACG plans to initiate about five joint clinical assessments (JCAs) for medical devices with the first assessments expected to start in June 2026. The Work Programme also sets out the 2026 schedule for Joint Scientific Consultations (JSCs).

On October 17, 2025, the European Commission adopted an implementing regulation that sets detailed procedural rules for Joint Clinical Assessments of medical devices and in vitro diagnostics under the HTA Regulation, which entered into force on 12 January 2025.

On June 2, 2025, the submission period for Joint Scientific Consultations (JSCs) requests under the EU Health Technology Assessment Regulation (HTAR) framework opened. JSCs offer health technology developers the opportunity to seek scientific advice on the information and evidence required for a potential future Joint Clinical Assessment (JCA). Requests related to both medical devices and medicines can be submitted until June 30, 2025.

On January 24, 2025, the European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices under the EU HTAR framework.

Starting January 12, 2025, Norway joined the EU Health Technology Assessment Regulation (HTAR) framework, a collaborative European initiative for method assessments. In 2024, a national working group assessed how to integrate HTAR into the "New Methods" framework. The Norwegian Medical Products Agency (NOMA) will be the key organization representing Norway and contributing to the development of Joint Clinical Assessments (JCAs) of medicines and medical devices.

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.