Germany is one of the few European countries with a structured, government-backed pathway that supports innovative medical technologies by temporary reimbursement - even when there’s not enough evidence for standard reimbursement.
Since 2012 the co-funded clinical study framework under §137e SGB V has given manufacturers a formal opportunity to secure interim coverage while generating robust clinical evidence for long-term reimbursement within statutory health insurance.
Our latest White Paper offers a deep dive look into this unique Coverage with Evidence Development scheme. It breaks down the strategic intent, legal underpinnings and step-by-step process of launching a co-funded study - whether initiated by manufacturers or triggered by regulatory assessments. With 25 study directives issued and 19 studies already underway across the German healthcare system, the report goes beyond theory, diving into how this pathway works in practice: from stakeholder roles and study design to cost-sharing models and critical differences between the inpatient and outpatient implementation. The case study perfectly illustrates the theory.
Designed for market access professionals at medical device and diagnostics companies, this report delivers practical, unembellished insights into one of Europe’s most structured and transparent evidence-based funding programs.
If you’re considering introducing a novel medical technology in Germany, understanding this scheme can help you navigate market entry and evidence requirements more effectively.
Request the full report to discover how Germany’s co-funded studies can turn clinical promise into reimbursement reality.
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Request analytical White Paper and advance your understanding of European market access for medical devices