European Commission adopts final implementing regulation for joint clinical assessments under the EU HTA framework 

The European Commission has adopted the final implementing regulation under the EU Health Technology Assessment Regulation (EU HTAR), setting detailed rules for joint clinical assessments (JCAs) of medical devices and in vitro diagnostic medical devices. The measure marks the completion of the regulatory framework needed to ensure consistent, evidence-based evaluation of health technologies across the EU. 

The new implementing regulation outlines how JCAs will be conducted under the EU HTAR framework, providing clarity on cooperation mechanisms, stakeholder engagement, and reporting procedures. The act defines how Member States, the European Commission, and other stakeholders will collaborate in assessing the clinical evidence underpinning these technologies, ensuring a harmonized and transparent process for evaluating clinical evidence. 

According to the European Commission, the regulation “provides detailed procedural rules for the joint clinical assessments,” covering cooperation between the Member State Coordination Group on Health Technology Assessment and the European Commission with notified bodies and expert panels. EU Health and Food Safety added that it also details: 

“How the Coordination Group and its subgroups will interact with health technology developers, patients, clinical experts, and other stakeholders.”  

The act further sets out general procedural rules for selecting and consulting stakeholder organizations and individual experts. It also introduces “the format and templates for dossiers with information, data, analyses and other evidence to be provided by health technology developers,” along with templates for JCA reports and summary reports. These standardized formats are designed to streamline processes and enhance the consistency and comparability of evidence assessments across the EU. 

This implementing act is the sixth and final regulation required for the full application of the EU HTAR, which became applicable on January 12, 2025. Together, the six implementing acts define the operational and procedural foundations for conducting joint assessments across Member States. 

The EU HTAR seeks to strengthen collaboration among Member States, reduce duplication in national assessments, and promote consistent, high-quality evaluations of new health technologies. By harmonizing methodologies and data requirements, the Regulation aims to improve efficiency, transparency, and the quality of evidence used to inform decisions on patient access and innovation. 

According to the Commission, nine joint clinical assessments are already underway for new cancer medicines and advanced therapy medicinal products, marking the first coordinated evaluations under the Regulation. In parallel, the HTA Coordination Group has completed its first joint scientific consultation (JSC), allowing developers to seek early advice from Member States on data generation strategies. “This is the first of seven such consultations,” the Commission confirmed, noting that two request periods were completed in 2025 and that additional rounds will follow in 2026. 

Commenting on the new regulation, Natalia Eitel of Vintura noted that it “provides detailed procedural rules for the joint clinical assessments,” including provisions for cooperation with notified bodies and expert panels, stakeholder engagement, and standardized reporting formats. 

EU Health and Food Safety described the adoption as “another big step forward in ensuring that innovative health technologies reach patients faster and more consistently across Europe.” It added that the new framework: 

“Contributes to our strong, unified HTA process, which ensures better evidence-based decisions, reduces duplication and accelerates patient access to safe, effective, and innovative technologies.” 

The adoption of this final implementing act marks the completion of the procedural groundwork for the EU HTA framework. One year on from when many of these details were still under development, the topic is sure to feature prominently at ISPOR Europe next month, where The Evidence Base will be reporting live from the conference. Together, these measures are intended to create a coherent, transparent, and efficient approach to assessing health technologies across Europe: 

“Another key step toward a more connected and equitable European health system,” 

according to EU Health and Food Safety.