On Friday 28 November, the annual HTA Work Programme for 2026 was adopted by the Member State Coordination Group on Health Technology Assessment (HTACG). The Work Programme outlines the key activities and strategic priorities of the group for the upcoming year. The HTACG estimates that it will initiate around 50 joint clinical assessments (JCAs) of …
The European Commission adopted an implementing regulation establishing the rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the joint clinical assessments, covering: Cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission …
The European Commission launched an online public consultation on joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level under the HTA Regulation. This online consultation will be open for responses until 25 June 2025. This public consultation is focussed on the last implementing act for adoption under the HTA Regulation, which will complete the …
The European Commission has launched the first request submission period for joint scientific consultations (JSCs) under the Health Technology Assessment Regulation (EU) 2021/2282. The JSCs enable health technology developers (HTDs) to exchange information with regulatory authorities on their development plans for a medicinal product or medical device. They also enable HTDs to obtain guidance on …
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 Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the joint scientific consultations, also known as scientific advice, covering: the submission of requests from health technology …
The Regulation on Health Technology Assessment (HTA) has become applicable, bringing a significant improvement in ensuring that innovative and effective health technologies are available to patients across the EU. The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU Member States. This …
The European Commission adopted an implementing regulation setting out the rules for joint scientific consultations on medicinal products for human use at Union level, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the joint scientific consultations, also known as scientific advice, covering: the submission of requests from health …