Germany MedTech Market
Executive Summary
Germany is Europe’s leading medical technology sector with a market share of 27%, employing approximately 210,000 people and generating nearly €55 billion in annual revenue. It is highly SME-driven (93% of companies are small/medium) and export-oriented, with about 68% of output sold outside of Germany. The market is innovation-focused, driven by an aging population and hospital modernization. U.S. firms should emphasize compliance readiness, long-term support and maintenance capabilities, and partnership models (joint ventures, local distribution) when approaching German buyers. Germany’s regulator - Federal Institute for Drugs and Medical Devices (BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte) actively publishes safety guidance, helping manufacturers manage regulatory and product-related risks.
Market Drivers
• Large, well-funded market: Germany devotes the highest share of GDP to healthcare (12.8%) which is higher than most other European countries. Its MedTech market is driven by steady replacement demand for equipment and diagnostics.
• Demographics and workforce: An aging population and a shortage of healthcare staff are forcing hospitals to adopt efficiency-enhancing technologies. Telehealth and remote-monitoring solutions are considered as key innovations to maintain care quality.
• Digitalization mandates: The German government has passed several laws (e.g. Digital Healthcare Act 2019 (Digitale-Versorgung-Gesetz – DVG), Digital Health Applications Ordinance (Digitale Gesundheitsanwendungen-Verordnung - DiGAV) which reimburses certified health apps and supports the expansion of e-health infrastructure. The Hospital Future Act (Krankenhauszukunftsgesetz für die Digitalisierung von Krankenhäusern) provides funding and deadlines for hospital IT upgrades (all hospitals must modernize by 2027), spurring demand for connected devices and IT systems.
• Innovation ecosystem: German MedTech companies invest heavily in R&D (≈9% of revenue) and benefit from about 50 regional clusters that link industry, research, and care providers. This networked environment accelerates development of AI, robotics, and digital therapies.
• Strong U.S.–Germany ties: The MedTech industry continues to show steady trade activity between the U.S. and Germany. For example, Germany imported about USD 3.17 billion in U.S. medical instruments in 2023.
In 2024, Germany exported EUR 31.8 billion in MedTech, with about 20% going to North America. From an importing perspective, the United States is Germany’s largest supplier.
Top Players in the German Market
• Siemens Healthineers (Germany) specializes in medical technology solutions, with a focus on medical imaging systems such as MRI and CT scanners, clinical diagnostics, and laboratory automation technologies.
• B. Braun Melsungen (Germany) develops and manufactures healthcare products including infusion and pump systems, surgical instruments, and orthopedic implants used across hospitals and clinical settings.
• Fresenius Medical Care (Germany) is a global leader in dialysis equipment and renal care services, offering products and solutions for kidney disease treatment, including home healthcare products.
• GE Healthcare (U.S.A) provides a broad range of medical technologies, including diagnostic imaging equipment, ultrasound systems, and patient monitoring solutions for healthcare providers worldwide.
(These are key players in the German MedTech market and represent both German market leaders and U.S. multinationals. Most of their sales occur through German partners or subsidiaries.)
Investment Trends
• Cross-border M&A activity: U.S. firms are actively investing in German HealthTech. In 2022, ResMed (US) agreed to buy German software firm MEDIFOX DAN (≈$1B deal) and later acquired Leipzig-based digital therapy company Mementor (maker of the “Somnio” insomnia app). These moves underscore U.S. interest in German digital health and cloud solutions.
• German firms investing in the U.S.: German companies also seek innovation abroad. For example, in 2025 B. Braun (GER) fully acquired True Digital Surgery (Goleta, CA) to integrate a cutting-edge 3D surgical microscope into its product line. These types of deals highlight growing transatlantic collaboration in advanced MedTech.
Market Entry Strategies
• Use local distribution: Most medical devices in Germany are sold via local channels. U.S. firms should consider appointing German distributors or establishing a subsidiary, as these partners know regional procurement rules and provide after-sales support. An agency or licensing agreement is common, but exclusive contracts can be hard to terminate under German law.
• Partner with clusters and hospitals: Leverage Germany’s health innovation clusters and research networks. Collaborating on pilot projects with major hospital groups or joining cluster consortiums can help a U.S. firm demonstrate its technology and gain credibility. For example, cluster programs often facilitate joint R&D or testing of new devices.
• Attend trade shows and connect with U.S. Trade Specialists: Germany hosts leading MedTech events (MEDICA in Düsseldorf, DMEA in Munich, etc.). These fairs attract hospital buyers, distributors, and government contacts. U.S. companies should exhibit or schedule meetings at these shows. The U.S. Commercial Service Specialists in Germany can also arrange partner searches and introduce U.S. firms to German health system stakeholders.
• Tenders: Public procurement plays a significant role in the adoption of medical technologies in Germany. Hospitals and healthcare providers frequently source equipment through EU-wide tenders published on the Tenders Electronic Daily (TED). In addition to this, national tender platforms such as evergabe.de and vergabe24 provide access to regional and sector-specific opportunities, although some features may require subscription access. Not all procurement processes are fully public, many hospitals procure through purchasing groups, including Prospitalia, Sana Einkauf & Logistik, and GDEKK. Engaging with these group purchasing organizations (GPOs) and understanding their tender requirements early can drastically improve market access and participation in large-scale procurement processes.
Challenges
• Regulatory hurdles: Compliance with the EU’s strengthened Medical Device Regulation (MDR) and IVDR is mandatory in Germany. Many products (especially “legacy” devices under old rules) require recertification. Navigating notified-body approvals and EU paperwork adds time and cost before market entry.
• Reimbursement and clinical proof: To gain coverage, especially for digital tools, companies often must demonstrate clinical benefit. The DiGA fast-track process exists, but even approved health apps face evaluation periods of up to 12 months and must show patient outcomes. Following this phase, pricing is negotiated with statutory health insurers. Companies are advised to plan early for evidence generation and engagement with reimbursement stakeholders during market entry.
• Data protection: Germany enforces strict data/privacy laws (GDPR, German Federal Data Protection Act) for any device collecting health information. Products must also meet CE marking and evidence-based efficacy standards. U.S. companies should plan for translation/localization and robust data security to comply fully.
• Procurement complexity: Public health insurance (statutory and private) covers most patients, thus adoption often involves competitive tenders and evaluation by committees. Price pressure is strong. Success typically requires strong local support (trainers, service) and familiarity with the German social code (SGB V- Sozialgesetzbuch).
Key Insights
Germany’s MedTech market remains a mature and innovation-driven sector, supported by strong healthcare infrastructure, an aging population, and increasing demand for digital and efficiency-enhancing solutions. Ongoing hospital modernization and the expansion of digital health technologies are creating sustained demand across both traditional devices and connected healthcare systems.
For U.S. companies, opportunities lie in partnering with local distributors, healthcare providers, and innovation networks, particularly in areas such as digital health, diagnostics, and hospital technologies. A partnership-oriented approach, combined with an understanding of regulatory and procurement processes, will be key to successfully entering and expanding in the German market.
U.S. DEPARTMENT OF COMMERCE, INTERNATIONAL TRADE ADMINISTRATION CONTACT INFORMATION
For additional Information, please contact:
Ulrike Riegeler
Commercial Specialist
Email: Ulrike.Riegeler@trade.gov
Phone: +49 69 7535 3157
Frankfurt, Germany