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The European Commission has launched a new opportunity for the developers of medicines, medical devices and in vitro diagnostics to seek scientific advice before reaching a formal assessment in Europe. a18> proceeding to a formal assessment in Europe.
The call for applications will be open from 23 September to 21 October 2026 and forms part of the new European Regulation on Health Technology Assessment, which comes into force in January 2025. Applications may be submitted by developers of medicinal products, Class IIb or III medical devices and Class D in vitro diagnostic devices.
The mechanism, known as joint scientific consultation,enables a company to discuss with the assessors what type of clinical evidence will be required at a later stage: the population included in the studies, comparators, variables, trial design or relevant data to demonstrate the value of a health technology.
This change is of particular relevance in areas where innovation involves complex studies: oncology, advanced therapies, high-risk devices, diagnostic tests linked to specific treatments, or technologies with an organisational impact within the healthcare system.
The European assessment has determined that both pricing and funding should continue to be a matter for individual countries, but it does aim to ensure that part of the clinical analysis is carried out in a coordinated manner, with less duplication and using criteria shared amongst Member States. The Commission therefore defines these joint clinical assessments as a means of supporting national health technology assessment processes.
Furthermore, Spain has also already adapted its legislation: Royal Decree 415/2026 regulates the assessment of health technologies and ensures alignment with European regulations. The text covers medicines, medical devices and other technologies, as well as non-clinical aspects such as economic assessment and ethical, social, organisational and legal issues.
For the healthcare system, the key issue is a practical one: there is a growing number of innovations with high prices, very specific indications and evidence that is not always easy to compare with what already exists. And within this context, assessing them properly before deciding how to incorporate them into the system becomes a crucial part of ensuring access.
There is also a channel open to patients, carers and clinical experts, as the European Commission has made information and templates available to gather input for joint clinical assessments and scientific consultations. In the context of complex technologies, this experience can help to better understand which outcomes matter in real life.
This opportunity is a preliminary, technical step, quite removed from clinical practice, but it will have an impact on something that does ultimately reach the system and which substantiates the evidence required of a healthcare technology before its adoption is assessed.
Sources
HaDEA / Comisión Europea — Health Technology Assessment: new opportunity to apply for Joint Scientific Consultations
https://hadea.ec.europa.eu/news/health-technology-assessment-new-opportunity-apply-joint-scientific-consultations-2026-09-22_en
Comisión Europea — Joint Scientific Consultations
https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-scientific-consultations_en
Comisión Europea — Joint Clinical Assessments
https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-clinical-assessments_en
BOE — Real Decreto 415/2026, de 27 de mayo, por el que se regula la evaluación de tecnologías sanitarias
https://boe.es/diario_boe/txt.php?id=BOE-A-2026-11587
Comisión Europea — Patients, carers and clinical experts involvement
https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/opportunities-patients-carers-and-clinicians/patients-carers-clinical-experts-involvement-faq_en