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

Area of Science:

• Health Technology Assessment (HTA)
• Medical Device Regulation
• European Healthcare Policy

Background:

• Transnational collaboration in medical device assessment is crucial for reimbursement decisions.
• Previous experiences and legal frameworks guide current collaborative efforts.

Purpose of the Study:

• To present the legal framework and past experiences in transnational medical device assessment for reimbursement.
• To discuss the benefits of transnational collaboration for diverse stakeholders.

Main Methods:

• Summarizing experiences from six joint rapid assessments within the European Network for Health Technology Assessment (EUnetHTA) Joint Action 2 (JA2).
• Describing the benefits, aims, and opportunities of the ongoing EUnetHTA Joint Action 3 (JA3).

Main Results:

• Challenges include topic selection, market transparency, and lack of European standards for patient involvement.
• Benefits include reduced uncertainty through Early Dialogues, improved report quality via harmonized processes, efficient resource allocation, and enhanced patient-centeredness.
• The EUnetHTA project's continuation underscores the importance of cross-border collaboration in HTA.

Conclusions:

• Sustainable transnational collaboration ensures cross-border healthcare and efficient national health system cooperation.
• Wide implementation of joint methods and quality standards is essential.
• European collaboration offers concrete benefits to patients, physicians, HTA organizations, and policymakers.