Setting High Quality Standards in EU Regulation on HTA: Applying an Adaptive Approach to assess the value of medical technology innovation along the lifecycle

The EU Regulation on HTA comes with a high uncertainty about its added value and how JCAs will be used in national HTA processes. The EU Regulation on HTA, however, also provides an opportunity to ensure high quality, timely assessments of innovations, avoid duplication and improve timely decision-making across Europe. For this opportunity to be realised, MedTech Europe believes it is essential that the Regulation is implemented in a way that supports the real-world decisions that patients and healthcare decision-makers need to make across member states to address unmet health and health system needs. This paper aims to contribute to the current debate on high-quality standards in the implementation and adoption of methods/guidance of the EU Regulation on HTA. While it seeks to explain what it is meant by an adaptive approach, why it is important, and how it can be applied in the context of the EU Regulation on HTA.

Read more in the discussion paper below.