[European Collaboration in Medical Device Assessment: One Step Towards Cross-Border Health Care].

AIM: The aim of this paper was to present the legal framework as well as previous experience in transnational collaboration regarding the assessment of medical devices for reimbursement decisions. Furthermore, the possible benefit of transnational collaboration for various stakeholders will be discussed.

METHODS: Experiences gathered with the compilation of overall 6 joint rapid assessments of medical devices within the completed European Network for Health Technology Assessment (EUnetHTA) Joint Action 2 (JA2) are summarised and discussed. Benefits, aims and opportunities of the ongoing EUnetHTA Joint Action 3 (JA3) are described.

RESULTS: Challenges in joint European assessment of medical devices encompass the choice of topics and the time point of assessments, the non-transparency of the medical devices market as well as the lack of European standards for systematic patient involvement. Characteristics of medical devices such as incremental changes and learning curves call for monitoring of medical devices through their whole lifecycle. The concrete benefit of European collaboration for stakeholders is manifold: uncertainties with regard to the actual added value of a technology, caused by a lack of evidence, may be reduced by Early Dialogues; harmonized and transparent assessment processes throughout Europe increase the reproducibility and quality of reports; the division of work among the health technology assessment (HTA) organisations allows a resource efficient assessment of a larger amount of technologies; patient involvement facilitates consideration of patient-relevant endpoints. The importance of cross-border collaboration in the field of HTA is shown in the continuation of the EUnetHTA project, which aims to further strengthen international collaboration even after expiration of EU funding.

CONCLUSION: A sustainable transnational collaboration in the assessment of medical devices can ensure cross-border health care as well as efficient collaboration of national health systems. The focus should be on a wide implementation of jointly established methods and quality standards. The European collaboration can lead to a concrete benefit for patients, physicians, HTA organisations and national decision makers.