Adaptive Evidence Generation and Health Technology Assessment

The EU Regulation on HTA brings significant uncertainty regarding its added value and how Joint Clinical Assessments (JCAs) will be used in national HTA processes. At the same time, it offers an opportunity to ensure high-quality, timely assessments of innovation, avoid duplication and improve decision-making across Europe.

To realise this potential, MedTech Europe believes the Regulation must be implemented in a way that supports real-world decisions by patients and healthcare decision-makers across Member States, addressing unmet health and system needs.

This paper contributes to the debate on high-quality standards in the implementation and adoption of methods and guidance under the EU Regulation on HTA. It explains what is meant by an adaptive approach, why it matters and how it can be applied in this context.