Germany - Country Commercial Guide
Healthcare and Medical Technology

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2021-11-16

Overview

Germany has a very robust and well-established medical equipment market. Brands such as Siemens, Carl Zeiss and Drägerwerk were founded at the end of the 19th century and vouch for the long history of producing high quality medical equipment, with an emphasis on diagnostic imaging, precision medical and dental instruments, and optical technologies. Germany claims the third-largest medical technology market in the world after the United States and Japan, and it is by far the largest European market, twice the size of the French market and three times as large as those of Italy, the United Kingdom and Spain. The German medical device market is one of the most lucrative healthcare markets worldwide accounting for roughly USD 35.8 billion annually, or 25.6 percent of the European market total.

The Healthcare/Life Sciences (HCT) industry is a priority for both the EU and Germany as reflected in the European Regional Development Fund (ERDF – or EFRE, in German) program and cohesion policy 2021-2027, as well as the German Länder implementation and tendering of this program. “Horizon Europe”, a European Incentive Program for Research and Innovation agreed upon by the EU Council and Parliament and retroactively entered into force on January 1, 2021 after final adoption in April 2021, also focuses on health and health-sector-related R&D and innovation. Projects target conquering cancer, smart health, aging, and digital models of care. All of this aims to increase opportunities for U.S. suppliers to participate in healthcare infrastructure, hospital development projects and to partner with German and EU firms. However, the German healthcare system, because of its decentralized and self-governing structure, is complex and slow in adapting new trends. German health minister Jens Spahn is determined to move the German health system into the digital age and has amended the regulatory environment with several laws to mandate progress. This will offer excellent export and partnering opportunities for innovative U.S. health solution providers throughout the health technologies supply chain.

Medical Technologies (MED) is the key sector of the HCT industry. The U.S. is home to the world’s leading medical device manufacturers. One in eight Americans is employed by the U.S. healthcare industry; there are 20 million medical-related jobs with about USD 1.0 trillion in annual payroll, according to the U.S. Census Bureau. Roughly 90 percent of the over 7,000 medical device manufacturers are export-ready SMEs, and many of the world’s largest medical device manufacturers are U.S.-based. All major U.S. suppliers, such as GE Healthcare, Johnson & Johnson, Becton Dickinson, Abbott, Abbvie, Thermo Fisher Scientific, Stryker, Zimmer, 3M, McKesson, Cardinal Health, Henry Schein, to name a few, have subsidiaries in Germany. Within the EU, Germany is the largest importer as well as exporter of medical devices (source: Medtech Europe, Facts & Figures 2021). U.S. medical device exporters continue to hold a 30 percent share of the German import market. Key industry drivers include the power of innovation, a solid financial basis of the industry (80 percent of which are SMEs) and a vibrant startup scene, all based on a strong German economy and the commitment to a high-quality health system.

Germany has a strong healthcare system, especially with regards to infrastructure, hospital beds and trained staff. In 2019, there were 494,300 beds in 1,914 hospitals (545 public hospitals, 645 non-profit and 724 private hospitals), 1,112 rehabilitation centers, and in 2020, the number of pharmacies was 18,753. Well-established infrastructure makes the healthcare industry the largest employer in Germany with currently 5.7 million employees (source: Health Ministry). Under a broader definition of the German Federal Ministry for Economic Affairs, 7.5 million employees in the health sector account for 16.7 percent of the total labor market. In 2020, the number of doctors was 372,000 and thus constituted a physicians’ density of 4.5 per 1,000 individuals, making Germany the country with the fourth largest density within the OECD. One out of six jobs in Germany is linked to the healthcare sector, which generates an economic footprint of EUR 678.2 billion (USD 798 billion), or roughly 12 percent of Germany’s GDP. With EUR 131.2 billion (USD 154.4 billion) generated through foreign sales, HCT contributes 8.3 percent to Germany’s total exports (source: BMWi). The German medical device market grew by 4 percent in 2019 and by 3 percent in 2020 despite COVID-related pressure on the industry. According to estimates by Fitch Solutions, the expected CAGR of the German medical equipment market for 2020-2025 is 5.1 percent in euro-terms and 6.8 percent in USD-terms. This projection is based on the expected improvement of the pandemic in Germany, with increasing vaccination and fewer cases reported. All these developments have enabled a strong economic recovery. Further growth factors include the digitalization of the health economy and tackling the double-digit investment backlog in the hospital market with the funds allocated by the Hospital Future Act. This law was enacted in October 2020 providing EUR 3 billion (USD 3.5 billion) of federal funding and additional EUR 1.3 billion (USD 1.5 billion) of state funding to modernize and digitalize the German hospital system.

Developments during the COVID-19 pandemic

The coronavirus outbreak continues to affect the German medtech industry in multiple ways. The industry has witnessed substantive changes in 2021, particularly with regards to the industry’s regulatory framework. Below are some key developments:

  • After initial postponement, the Medical Device Regulation (MDR) has been fully in force since May 26, 2021. Based on the MDR, the new German law for medical devices MPDG (in German, “Medizinprodukterecht-Durchführungsgesetz”) and the Medical Device-EU Adaptation Law provide a European framework for the German market; the MPDG replaced the established MPG (in German, “Medizinproduktegesetz”) law on May 26, 2021. The In-Vitro Medical Devices Regulation application date, May 26, 2022, remains unaffected.
  • On April 3, 2020, the EU Commission announced temporary suspension of custom duties and VAT for medical equipment to aid EU Member States in receiving necessary protective equipment and medical devices, including masks, protective gear, testing kits, ventilators. On April 19, 2021, the European Commission agreed to extend this suspension until December 31, 2021, with a possibility of further provisions depending on the development of the pandemic in the EU.
  • The EU Commission has published guidance to outline temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions to ensure the availability of safe medical devices and to prevent shortages. 
  • Medical and non-medtech related enterprises have redirected production to meet the surging demand for personal protective equipment and vaccines. These efforts led the Health Ministry to announce the removal of the vaccine priority system on June 7, 2021, making it possible for every person above 12 years of age to receive protection.
  • Automotive and general industrial manufacturers; general textile manufacturers; and online platform providers such as Amazon, Apple and Alibaba, entering the health technology markets with COVID-19 products and solutions and set to stay in the healthcare arena, disrupted the previously rather consolidated market with new business models.
  • Despite the improvement of pandemic-related parameters, trade show responses have been mixed with some major trade shows such as MEDICA and the IDS-International Dental Show planning to hold hybrid events with in-person attendance in 2021, while others canceled or postponed their trade shows. Some organizers decided to offer virtual conferences such as the T4M (“Technology for Medical Devices”) in Stuttgart.

The rising demand for medical equipment has boosted this sector’s economic growth and has incentivized the German government to further increase its investment in innovative medical technology. For example, the Federal Ministry of Education and Research announced on April 7, 2021, that it will increase its medical technology funding by further EUR 20 million (USD 23.7 million) to adequately address the needs of COVID-19 patients and to modernize the healthcare system. This additional funding should support medical technology manufacturers, hospitals, research facilities and SMEs. Besides increased funding, the market experienced other changes. German medical association SPECTARIS in cooperation with Roland Berger conducted a survey to identify recent and future market trends. Those include greater digital distribution and services, new business models for a digital environment, pressure on prices due to reduced revenues by health insurance companies and that in-vitro diagnostics, robotics/automation and smart wearables will benefit the most in this market.

The pandemic has illustrated how complex the supply chains and production networks are in this industry; uncertainty continues to disrupt normal operations as countries have become more protectionist. These political interventions have led to more difficult investment environments, export reductions and capacity constraints. Some branches of the industry recorded revenue reductions of up to 40 percent. According to a survey conducted by German medical industry association, BVMed, firms deem an increasing regulatory framework, such as the introduction of the Medical Device Regulation (MDR), as a main growth barrier. The MDR even led some highly specialized firms to discontinue operations as the additional cost of compliance exceeds possible revenues, creating a shortage of certain equipment for hospitals.

The pharmaceutical industry has seen a shift of resources towards the development of coronavirus drugs and treatments at the expense of new drug introductions in traditional segments. Disrupted supply chains resulted in a medicine shortage in Germany in 2020, when suddenly up to 68 percent of necessary drugs were unavailable. The German Federal Institute for Drugs and Pharmaceuticals (BfArM) created a list of 22 key substances, such as insulin and antibiotics, whose production should be reintroduced in the EU. Specific supply of critical drugs, and the establishment of local production facilities, prove to be possible avenues of investment in the EU and particularly Germany. Those critical products already constituted sales of approximately USD 7.1 billion in 2020. Securing local production requires constant innovation, as exemplified by Pfizer’s green factory in Freiburg, whose energy consumption is covered by 90 percent green energy. The EU acknowledges this innovation potential and paves the way for funding modern, digitalized production facilities. At the same time, cooperation has become a central element during the pandemic as 15 pharmaceutical and biotechnological companies have agreed to share their research data in a common database, highlighting that continued challenges provide further transatlantic commercial and research opportunities.

The pandemic has also boosted the collaboration between startups and large corporates. A prime example of exponentially successful cooperation is the BioNTech-Pfizer venture. The boost is seen in large increases in funding, on the stock market and capital market. Positive market developments require a growth-promoting regulatory framework, which allows for easier capital inflow, access to capital and tax incentives. Here, Germany has room for improvement and is also still highly conservative. Fear of selling out German industry experience and knowledge, as well as the goal to secure the medical ingredient supply chain has resulted in greater regulatory hurdles. Still, optimism remains high as investors recognize this sector’s strong growth potential. The listing of CureVac and Immatics on the stock market in 2020 and BioNTech’s continued success on the stock market is proof of interest surge in promising biotech companies among investors.

COVID-19 also requires a new approach towards patients. Already before the pandemic, a growing interest among consumers in a healthy lifestyle and its optimization could be witnessed. The pandemic amplified the willingness to use health apps for health-related information and monitoring. Connected with this is a growing demand to receive tailored medical treatment based on collected data. Either specialized or holistic medical applications are readily sought after. Lockdowns have quickly established remote consultation as a main method of medical communication. In 2019, only 583 doctor’s appointments were conducted via video call or phone, while between March-June 2020, this number rose to 1.2 million, showing that the expansion of the digital infrastructure is indispensable.

Market Entry and Best Practices

The German market for medical devices is regulated by German and EU directives, standards, and safety regulations. After a one-year delay of the start date of the EU Medical Device Regulation (MDR), which introduced increased testing, certification and compliance requirements, this regulatory framework has come into full effect on May 26, 2021. The complementary In Vitro Diagnostic Regulation will be enacted from May 2022. U.S. exporters are well-advised to become informed about MDR and obtain public or private sector counseling and assistance of the possible impact of their market entry plans into Germany. Companies seeking market entry should also carefully map their distribution strategy depending on their target group(s). CE marking is mandatory for selling into Europe. Entry strategies to be considered are top-down or bottom-up marketing, picking the right partners and ensuring patient- and customer-centric system solutions and support. Most medical equipment imported into Germany is either sold directly through a local subsidiary with a field sales force, through medical distributors with an established distribution network (often on a regional/territorial basis) or through appointed agents or manufacturer representatives. Local representation or market presence is essential when considering differing standards and certifications, warehousing costs, maintenance, accessibility, and local marketing/sales preferences/discussions. An agency agreement is often a cost-effective mechanism to enter the market, but under German law – even if the agent’s performance is not satisfactory – it can be difficult and costly to terminate an exclusive arrangement. A representation or distributorship agreement may be more difficult to arrange, but the German associate will, in fact, purchase the product to be sold, thus sharing the market risk. Licensing, partnering with large corporate partners or buying a local firm provide alternatives in times where traditional distributors are bought up by corporates and the market increasingly consolidates. Further information is available in Commerce’s Global Markets Healthcare Team’s annual Healthcare Technologies Resource Guide.

The German Medical Equipment Market 2019-2022 (USD billion)

 

2019

2020

2021 (proj.)

2022 (proj.)

Market Size

35.0

36.7

39.2

41.9

Local Production

37.6

40.5

43.3

46.2

Imports

20.2

22.7

24.2

25.9

Exports

22.8

26.5

28.3

30.2

Imports from the U.S.

4.9

6.8

7.3

7.8

Total Market Size = (Total Local Production + Total Imports) – (Total Exports)

Data Sources: Spectaris Trade Association; BVMED Trade Association; Medtech Europe; Statista (German Federal Statistics Office); Fitch Solutions

General statistics on Germany is available by the German Federal Statistics Office.

Leading Sub-Sectors

Leading HCT sectors include Health IT, pharmaceuticals, dental products, and biotechnology.

Health IT: The German Health Ministry and its agency, Health Innovation Hub, are ambitiously implementing the Digital Care Act and digital health solutions, called “DiGA”. DiGA Fast Track is Germany’s path for digital health solutions to get access to the German statutory health system, reaching over 75 million German citizens insured under the mandatory health insurance. The German Health Ministry’s subordinate agency, the Federal Institute for Drugs and Pharmaceuticals, BfArM (German equivalent to the FDA) is taking online applications for DiGAs, and once approved as a medical app, DiGAs can be prescribed by any German physician. DiGA providers will be reimbursed by German insurance funds. Likewise, the telematics infrastructure, including 5G rollout, is being developed at a dramatic pace, and the electronic medical record (in German, ePA) is taking shape. From January 1, 2021 German health insurers are mandated to provide their insured with the ePA; and from July 1, 2021 all statutory health insurance accredited physicians and psychotherapists must be able to read and fill in the ePA. This law also facilitates easier access to patient data for research purposes as healthcare providers transmit their patient records to a centralized government-owned server.

The Hospital Future Act and its funding allow German hospitals to speed digitalization and remain competitive globally. So far, there has been an innovation gap in the German hospital sector because of lacking focus for digitalization among the German health policy makers and hospital management for years and there is still an insufficient number of dedicated digital solution providers. Thus, this market is especially penetrable for U.S. digital solution providers. E-medication is also on its way, with the new paragraph 360 of Germany’s SGB V social law, relating to the Patient Data Protection Act (PDSG). It mandates doctors and dentists to issue prescriptions in digital format from January 1, 2022. The law also makes it clear that even with digital prescriptions, the free choice of pharmacy of the insured remains, and neither health insurance funds nor contract physicians have a right to assign or influence. On July 1, 2021, an app for digital prescriptions was launched on all major mobile device app stores by the government-controlled firm, Gematik. Concurrently, pilot projects began in Berlin and Brandenburg, involving 50 doctor’s offices and 120 pharmacies testing the new format. Testing will be expanded to all of Germany on October 1, 2021. These steps will be decisive for Germany to catch up to its EU neighbors and will present excellent opportunities for U.S. HealthIT providers. HealthIT applications currently represent more than USD 450 million, with numerous projects throughout Germany and a University Hospital excellency network, which drives innovation in treating key diseases such as stroke, Alzheimer’s, cancer, and diabetes. An aging society (with a significant share of chronic disease), the rollout of e-health patient portals by public health plan providers, high internet and mobile phone penetration make Germany a strong HealthIT market and offer valuable potential to specialty solution providers. The digital health ecosystem in Germany will be driven by cloud computing solutions, artificial intelligence (AI), robotics, smart wearables, big data analytics, and the Internet of Medical Things (IoMT). The German Ministry of Health maintains a website on digitalization in healthcare; the German Ministry of Education and Research maintains a website on the medical informatics initiative. As of January 1, 2021, Germany’s BfArM-German Federal Institute for Drugs and Medical Devices is a member of SNOMED International, global standards organization for health terms. With full membership, all German institutions and specialist groups in the healthcare sector wishing to use SNOMED CT in their applications can apply for a free license from BfArM. More information can be found on the SNOMED website.

Germany has an excellent base for HealthIT, with over 80 percent of its workforce holding a degree, and a startup-friendly environment. This makes it a very strong market for m-health and e-health products and services. The strong German medical technology clusters develop telehealth and telemedicine solutions and form excellency clusters for oncology, neurological disorders, and chronic disease management in cooperation with hospitals and industry. The German government’s medical informatics initiative aims at improving medical R&D and patient care through innovative IT solutions for specific applications and integrated health data centers. This multi-million-dollar funding resource should pose excellent opportunities for U.S. solutions providers. E-procurement and e-commerce, Machine-to-Machine communication (M2M), mHealth/apps and big data applications are areas of digitalization, in addition to telehealth and telemedicine, with windows of opportunity for U.S. suppliers.

It is strongly recommended to open an office in Germany or work with a knowledgeable partner to enter the German HealthIT market, which is dominated by some large players in the various segments, i.e. Compugroup, Deutsche Telekom Healthcare, Siemens Healthineers, i-Solutions, Nexus, Visus, to name a few. 

Pharmaceuticals: The German pharmaceutical market was valued at USD 76 billion in 2020 and remains one of the most attractive worldwide over the coming years. It accounted for 15.6 percent of total health expenditures and 2 percent of GDP. Annual per capita spending is above average at USD 907, with prescription medication contributing 87.6 percent (from 69 percent, but this was the number for patented drugs) to the total. According to market analysts, the German pharmaceutical market is expected to grow by an average of 4.2 percent in euro-terms, and 6.1 percent in USD-terms annually until 2025. Major growth drivers are the aging population and chronic diseases. Germany counts over 520 pharmaceutical companies; many global U.S. corporations such as Pfizer, Eli Lilly, Abbott, and others have production facilities in Germany. Germany is regarded as a test market for other EU countries for pricing and distribution and it is a good location for API (active pharmaceutical ingredients) production. In 2019, the German pharmaceutical industry manufactured products worth USD 37 billion, a decrease of 13.7 percent over the previous year. For the same year, exports of pharmaceuticals decreased by 6 percent, generating sales of USD 86.3 billion, while imports grew by 2.4 percent, amounting to USD 55 billion. For 2020, exports of pharmaceuticals increased by 6.4 percent, generating sales of USD 91.8 billion, while imports grew by 8.7 percent, amounting to USD 59.8 billion.

Biopharmaceuticals: Sales of biopharmaceuticals in 2020 (pharmacies and hospital market) grew by 14 percent to USD 17.6 billion (EUR 14.6 billion) compared to 2019. The market share in the total pharmaceutical market rose from 29 percent to 30.8 percent. Growth was seen in nearly all fields of application. Among current focus areas are ATMPs (Advanced Therapy Medicinal Products), such as gene therapy products, cell therapy products, and tissue engineered products. Compared to classical medicines, where the active substance consists of a chemical molecule or protein, ATMPs are nucleic acids (such as genes) or can be whole cells or tissues. While classical medicines for the treatment of hereditary diseases usually require life-long use, ATMPs could achieve long-lasting therapeutic efficacy, possibly even a cure, after one use. The German term for ATMPs translates to ‘novel therapies’ and emphasizes the innovation aspect, which is reflected in their development, production, approval and market access, and reimbursement process.

Medical Biotechnology: Germany is Europe’s largest biotechnology market. In 2020, 710 dedicated[1] biotechnology companies (+1 percent to 2019) generated sales of USD 7.7 billion, a 36 percent growth over 2019. The number of employees in the biotech industry increased to 37,415, up 10 percent. This significant market growth is largely attributable to the key players listed on the stock exchange: Among Germany’s dedicated biotech firms, the 23 listed companies generated roughly 49.3 percent (+43 percent compared to 2019 due to a pandemic-related demand surge) of overall industry sales. Of these major players QIAGEN, Evotec, and BioNTech alone contributed 44 percent to the market sales total. It is especially noteworthy that during this year, Morphosys registered a 357 percent growth, BioNTech a 344 percent growth rate and the COVID-19 diagnostics firm CENTOGENE a 59 percent increase. R&D spending stood at USD 2.9 billion, an increase of 37 percent over 2019. Growth in spending was again attributable to the small number of listed companies, whose expenditure amounted to approximately USD 1.67 billion, or 58 percent of all R&D expenditures (+66 percent), privately held firms recorded a substantial increase in R&D of 11 percent. Growth sectors in Germany’s biotech industry continue to focus on new drug development and diagnostics, such as early disease detection, infectious diseases, and rare diseases. The pandemic has especially created a financial incentive to expand the development and sales of vaccines. In-vitro diagnostics (IVDs) are an important growth driver in the market, since two-thirds of all clinical diagnoses are made through IVDs. With more than USD 3.2 billion (+27 percent compared to 2019) in annual sales, Germany represents the largest IVD market in Europe and second worldwide behind the USA. Germany’s biotech clusters are Europe’s leading research and development hubs, and important partners for industry/academic R&D and technology transfer. Biotech is strong in Bavaria; North Rhine-Westphalia; Baden-Wuerttemberg; and the Berlin-Brandenburg region. Some of the largest and most reputed clusters are in the Rhine-Neckar Triangle (Heidelberg), Cologne/Dusseldorf, Berlin/Brandenburg and Munich. Biotech is a priority for EU and German governments and is central to Germany’s innovation and high-tech policies. Biotech action plans focus on diagnostics, therapy and preventive medicine in bio-medical research and care, and research-based bio-medical technologies in specialized clusters. Germany’s participation at the BioEurope trade show, and in the world’s leading annual biotech event, BIO Convention, in the United States, with an official Germany Pavilion, shows the commitment and close transatlantic ties in this health tech subsector. 

Dental products: Germany is Europe’s largest market for dental equipment valued at USD 2.48 billion in 2019. For the first time since 2015, total sales of dental products from 207 mostly medium-sized member companies of the Association of German Dental Industry (VDDI) decreased to USD 5.7 billion in 2020 (-13.1 percent compared to 2019) and an export share of 60.6 percent with USD 3.5 billion (-16.5 percent compared to 2019). These firms represent 85-90 percent of the German dental market and employ more than 21,290 people. Even though VDDI’s numbers constitute a market contraction, the firms that participated in their annually conducted market survey, remain optimistic. 59 percent of the survey firms expect exports to increase in 2021 compared to 2020, while 32 percent expect similar numbers and only 9 percent have negative expectations. A similar pattern can be seen with their evaluation of the German market. 51 percent expect sales to increase, while 42 percent anticipate similar sales and only 7 percent think their revenue will decrease. The Federal Dentists Chamber, BZAEK, expects the workforce in the dental industry to increase by 18.6 percent in the period 2010-2030, from 410,000 to 486,000 employees. This includes dentists’ offices, dental labs, and the trade with dental products. Estimates by Fitch Solutions reveal a forecasted CAGR of 7.6 percent in euro-terms and 9.3 percent in USD-terms for this industry.

Digitization with advanced 3D imaging and printing, the use of CAD/CAM systems and robotics as well as innovation in dental materials and minimally invasive techniques have a major impact on market development. Another key factor contributing to Germany’s dental market growth is the increasing dental health awareness among its population and an increasing willingness and ability to pay for preventative and corrective treatments.

U.S. exports to Germany amounted to USD 126 million for dental equipment and supplies, and USD 55.2 million for dental laboratory products in 2020. Over 200 U.S. companies are actively exporting, with heavyweights Henry Schein, Danaher Corporation and Dentsply Sirona holding a direct presence and major market share. The major U.S. dental technology supplier Henry Schein is one of the largest distributors in Germany’s dental market, with annual sales of more than USD 126 million and an estimated 5 percent market share in 2020.

Severe impairment of the dental industry by the corona crisis

National and even global lockdowns and curfews have restricted the social mobility of people to reduce the risk of infection. This has resulted in a sharp drop in demand from patients for dental care which was exacerbated by a lack of PPE for dental practice staff. A sharp rise in worldwide demand quickly led to bottlenecks in supplies, and dentists saw their obligation to treat patients endangered. Stockpiling by market players from outside the industry led to temporary bottlenecks for disinfectants and anesthetics, and suppliers of basic materials were unable to deliver the usual amounts. Suppliers of materials and containers were no longer able to deliver, and well-established supply chains collapsed.

The United States is a technology leader and is competing with Germany in large markets such as China and India. Both the U.S. and Germany have branded for top quality products and innovative technologies and have strong trade ties. Traditionally the leading global trade fair for the dental community, the IDS-International Dental Show in Cologne proves to be an arena where both the U.S. and Germany demonstrate strength and forge further ties in R&D and trade, in view of increasing Chinese competition. Staged biennially, the U.S. dental industry is represented by 200+ U.S. exhibitors in two USA Pavilions and independent exhibits; this number has remained solid over the past ten years with 15-20 percent newcomers at every show, except for the 2020-21 pandemic years.

Policy Objectives and Challenges

The Commercial Service is working to evaluate the broad impact of the EU Council’s respective health policy goals, as follows:

  • Europe to find ways to re-shore the manufacture of essential medicinal products and medical devices (such as face masks) to Europe and build a European stockpile.
  • Europe to become more attractive for research. This requires data. Europe to drive the creation of a European health data space and a respective code of conduct for dealing with patient data.
  • European public health organizations such as ECDC and EMA to be strengthened to allow them to work on equal terms with their U.S. counterparts.

We collaborate with the local German MED clusters and their members on EU and German trade policies such as the MDR, IVDR, the SPC-Supplementary Protection Certificate for manufacturing pharma, IP and cybersecurity issues, with a focus on SMEs and countering malign third-country influence. We also report major procurement deals and opportunities to U.S. businesses and encourage a positive outlook on transatlantic trade among industry contacts we meet at events and in the context of partner search outreach.  

A short overview of the state-of-play of joint assessments of notified bodies in the medical device sector is available now from the European Commission’s webpage “Medical Devices - Sector - New Regulations - Implementing measures for Regulations”.

We are following the latest healthcare policy developments and discussions in Germany, and work with U.S. associations, such as the Advanced Medical Technology Association and PhRMA-Pharmaceutical Research-based Manufacturers Association based in Washington to ensure fair access, standards interoperability, and IP protection for U.S. firms to and in the German and European markets.

Opportunities

Germany’s healthcare market offers more than just agents and distributors; it has various opportunities along the value supply chain route: Design and research and development collaboration; strategic partnerships; equity partner and investor engagements; mergers and acquisitions; project collaboration, and other types of opportunities for SMEs to grow business and expand in the market. For example, the U.S. National Institutes of Health (NIH) plans to promote clinical study capabilities and resources to innovative German and European life science startups and SMEs during BioEurope, a road show, and virtual events in 2022. Combining the resources of NIH and the networks of the German life science clusters, we will see a unique and powerful partnership that will bring the most innovative and brightest solutions to the U.S. market, and help both economies to grow and create jobs. In addition, we will assist major U.S. players in the Healthcare Cybersecurity arena, such as Palo Alto, Tanium and InterSystems, gain further visibility and brand awareness in Germany and German-speaking Europe with seminars around cybersecurity and ransomware attacks in hospitals and other medical facilities. Likewise, the U.S. German Digital Health Forum initiated by the U.S. Commercial Service in partnership with a major German digital health platform continues to expand and opens the door to innovative U.S. digital health solution providers and allows them to forge relationships with university hospitals in Germany.

The German government’s health informatics funding initiative and the German states’ initiatives on healthcare digitization offer prime opportunities for U.S. firms to engage in Germany. An example would be a procurement for North Rhine-Westphalia’s Public Hospitals to re-organize their system and reconstruct and upgrade existing facilities. In a four-year span, U.S. companies will have the opportunity to participate in consortia or as sub-contractors.

The German government’s “Medical Informatics” funding scheme as part of the Health Research Framework Program offers an aging society where diseases like cancer, dementia and various cardiovascular, metabolic, and muscular ailments will become more prevalent, to improve the exchange of data across different institutions and locations. The aim is that faster diagnoses and treatments will help to cut costs and help individuals receive faster and more precise care.

For more information on procurements you can get involved in, please contact us via our website to be added to a regular email of tender opportunities, or visit Tenders Electronic Daily by the EU.

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[1] is defined as a biotechnology active firm whose predominant activity involves the application of biotechnology techniques to produce goods or services and/or the performance of biotechnology R&D