Pricing and reimbursement decisions for new healthcare technologies and treatments begin with a health technology assessment (HTA). The EU’s Health Technology Assessment Regulation (EU) 2021/2282—often called the HTA Regulation (HTAR)—represents a major shift in how medicines and certain medical devices are evaluated for clinical benefit at the EU level. Adopted in December 2021 after protracted negotiations, the HTAR creates a permanent framework for joint clinical assessments (JCAs) of new health technologies, replacing the previous system of voluntary, project-based co-operation. It aims to streamline evidence generation, avoid duplicate national HTA efforts, and ultimately support faster, more evidence-based access to innovative medicines and devices across Europe. Ultimately, the HTAR establishes a harmonised framework for assessing the clinical effectiveness and safety of new medicines and certain high-risk medical devices across the EU. HTAR entered into force on 11 January 2022 and began its application from 12 January 2025 for oncology medicines, advanced therapy medicinal products (ATMPs) and certain medical devices. Throughout 2024–25, the European Commission adopted six Implementing Regulations, while the Member State Coordination Group on