Up to now, each EU country has done its own assessment of new health technologies, such as medicines, medical devices, or diagnostic tests. This has often resulted in duplication, delays, and unequal access for patients.
The new EU HTA Regulation (2021/2282) introduces a more unified and efficient process for evaluating these technologies at the European level. Implementation began in early 2025 and is being phased in gradually.
Under the new system, the EU will:
- Conduct Joint Clinical Assessments (JCAs) to evaluate the clinical effectiveness and safety of health technologies at EU level
- A Joint Clinical Assessment (JCA) is the main product of this new European collaboration on health technologies. It looks at how effective and safe a new medicine, medical device, or diagnostic test is compared to other available options.
The assessment focuses on:- The benefits (e.g. living longer, fewer symptoms)
- The risks or side effects
- The quality of the evidence, based on how the studies were done
- The final JCA report is shared with all EU countries. Each country then uses it, along with other national criteria, to decide how to use the technology in their health system. 📘 EU Commission – JCA for Medicinal Products Factsheet (PDF)
- A Joint Clinical Assessment (JCA) is the main product of this new European collaboration on health technologies. It looks at how effective and safe a new medicine, medical device, or diagnostic test is compared to other available options.
- Provide Joint Scientific Consultations (JSCs) to give early advice on how to generate the right clinical evidence
- Involve patients and experts from across Europe
- Share one JCA report with all EU countries (focused on clinical evidence only)
This shared approach will reduce duplication, promote equal access, and strengthen the role of patients and experts in shaping health technology decisions.
🎥 Watch: EUCAPA – Module 2: EU HTA Regulation (12:37)