Today, 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 with the notified bodies and with the expert panels;
- Interaction between the Coordination Group, its subgroups and health technology developers, patients, clinical experts and other relevant experts;
- General procedural rules on the selection and consultation of stakeholder organisations and individual experts;
- The format and templates for dossiers with information, data, analyses and other evidence to be provided by health technology developers;
- The format and templates for joint clinical assessment reports and summary reports.
The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation. This is the sixth and last implementing regulation to ensure the proper application of the HTA Regulation. The HTA Regulation became applicable on 12 January 2025 and to date, nine joint clinical assessments are ongoing for new cancer medicines and advanced therapy medicinal products.
Another significant milestone is the conclusion by the HTA Coordination Group of the first joint scientific consultation, where health technology developers get advice on their data development from the Member States. This is the first of seven such consultations which started, following two request periods where health technology developers could submit their requests to have a joint scientific consultation in 2025. More request periods will follow in 2026.
Excerpt from the official page. The original is authoritative.