The Health Technology Assessment Regulation (HTAR), officially known as Regulation (EU) 2021/2282, marks an advancement in the evaluation of health technologies within the European Union. Effective from January 12th, 2025, the HTAR aims to harmonize the assessment processes for health technologies, including medical devices (MDs) and in vitro diagnostic medical devices (IVDs), across EU member states.
Key objectives of the HTAR
The primary objective of the HTAR is to establish a structured and legally binding process for evaluating the relative clinical effectiveness and safety of health technologies at the EU level.
At the core of this process are the joint clinical assessments (JCAs), entailing a scientific evidence-based “analysis of the available clinical evidence on a specific health technology in comparison with one or more other health technologies or existing procedures, addressing a specific health problem”.
Once published, EU Member States will have to give due consideration to the JCA outcomes in their own national HTA reports. The information thus generated will allow national competent authorities to determine the relative effectiveness of new or existing health technologies and inform policymaking for the purpose of reimbursement and price negotiations at national level.
What’s in scope?
Under the HTAR, the implementation of JCAs is planned to be phased over time. Starting from 2025, JCAs will be mandatory for cancer medicines containing new active substances, advanced therapy medicinal products and a selection of high-risk MDs and IVDs. From January 2028, orphan medicinal products will be added to the list, and from 2030 all new medicinal products will be in scope of the HTAR.
High-risk MDs and IVDs
The following high-risk devices shall be subjected to JCAs:
- Class IIb active devices intended to administer and/or remove a medicinal product and class III implantable MDs for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure.
- Class D IVDs for which the relevant expert panels have provided their views in the framework of the performance evaluation consultation procedure.
Implementing acts will be released by the European Commission at least every two years to define which, among the high-risk devices listed above, will be selected to fall under the scope of the JCAs.
Importantly, according to the HTAR, the mandatory JCA process for high-risk devices should not delay or interfere with CE-marking of MDs and IVDs, nor should it delay their market access. Once the certification is obtained, manufacturers of devices falling under the scope of JCA are expected to contact with the HTA Secretariat and submit a summary of all the relevant clinical data supporting the device’s safety and clinical performance. Further guidance on how the application process will formally look like for MDs and IVDs is expected shortly.
What can I do as a manufacturer?
As a manufacturer of a high-risk device, it is advisable to ensure that robust processes are implemented for the collection and analysis of clinical data. Clinical evaluation (MD) and performance evaluation (IVD) reports are key documents in the dossier which the manufacturer is expected to submit for JCA.
To stay informed about the selection process for high-risk devices under the HTAR, and seek guidance on the actual application process, manufacturers are advised to:
- monitor the Official Journal of the European Union for newly published implementing acts (EU law – EUR-Lex),
- monitor official EU resources on the HTAR (Implementation HTAR; Key documents; Latest updates)
- engage with relevant industry associations and the HTA Stakeholder Network (HTA Network).
Talk to us at QAdvis for professional advice – we are always nearby and can help you navigate the new HTA Regulation!
