Insights

The European Commission has officially completed the EU Health Technology Assessment (HTA) framework by publishing the final implementing act that defines how Joint Clinical Assessments (JCAs) will be conducted for medical devices and in vitro diagnostics (IVDs) under Regulation (EU) 2021/2282.

Published on 17 October 2025, this is the sixth and last implementing act required for the full application of the HTA Regulation, which became effective on 12 January 2025. The implementing act enters into force on 9 November 2025, marking a major milestone in building a unified, transparent European HTA system.

Key Points

• Establishes procedures for cooperation between Member States, the European Commission, notified bodies, and expert panels.
• Defines how developers, patients, and clinical experts are engaged throughout the assessment.
• Introduces standard formats and templates for dossier submissions and joint assessment reports.
• Clarifies processes for stakeholder consultation and evidence presentation, ensuring consistency across Member States.

Why It Matters

This regulation provides clarity and predictability for medical device and diagnostic manufacturers entering the EU market.
For regulatory, legal, and market access teams, it is time to:

• Align evidence-generation strategies with JCA requirements;
• Prepare dossiers following the new templates;
• Plan early stakeholder engagement with clinical and patient organisations.

The completion of the HTA framework represents a shift toward harmonised, patient-centred assessments that will streamline access to innovative technologies across Europe.

RPN remains committed to monitoring regulatory developments and providing timely insights to help stakeholders navigate the evolving landscape of health technology assessments in Europe.
Through continuous engagement and expertise in regulatory affairs and market access, RPN supports companies in aligning their strategies with the latest EU requirements to ensure successful and compliant market entry.