Current Market Trends
Population: 82.71 million (2017)
GDP: US$3.26 trillion (2017
The German Medical Equipment Market 2016-2018
Imports from the U.S.
Total Market Size = (Total Local Production + Total Imports) – (Total Exports)
Data Sources: Spectaris Trade Association; BVMED Trade Association; Eucomed; Statista
General statistics on Germany is available https://www.destatis.de/EN/Homepage.html. This information is published by the German Federal Statistics Office.
Healthcare is one of the key sectors in the German economy. Medical and pharmaceutical manufacturers employ more workers than the automotive industry, totaling 900,000 jobs in 2016 according to the German Federal Economics Ministry. Adding the supplier industry and service providers, the figure jumped above the 7-million-jobs mark for the first time in 2016. Physicians, hospitals, the care industry, medical and pharma manufacturers generated a gross value added of 336.4 billion Euros in 2016, growing an average annual 3.8%, notably stronger than the overall economy. The health economy in Germany made up 12% of total gross domestic product in 2016. Germany has a long history of producing high quality medical equipment, with particular emphasis on surgical instruments, diagnostic imaging, dental products, and optical technologies. Not only is Germany the third largest market in the world after the United States and Japan, but also 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 devices market ranks no. 1 in Commerce’s Top Market Reports.
Germany is both a competitor and partner of the United States in the global MedTech market. The German market is highly sophisticated and competitive, and continues to consolidate with corporates purchasing, traditional distributors, and emerging niche market providers to expand their range in customers and markets. It is also a conservative market and it commonly takes 1-2 years to create brand awareness, and 5-6 years to market successfully. U.S. suppliers should carefully consider their market entry options, including setting up an office and selling direct, partnering with a corporation, regional coverage, and online distribution. Good website localization is a must for companies seeking expansion, as well as finding after sales service and support, preferably in-country.
Germany has a strong healthcare system in terms of infrastructure, hospital beds, and trained staff. In 2016, Germany counted 498.8 thousand beds in 1,951 hospitals (of these, 570 public hospitals; 674 non-profit, and 707 private hospitals), 2,500 medical supply stores, 1,151 rehabilitation centers, 20,023 independently owned pharmacies, and 140,000 doctors’ offices. Germany counted 378,600 medical doctors in 2016.
German healthcare expenditures are high and linked to great strides towards cost-containment. In 2016, total expenditures increased 4.9% to 374.2 billion Euros, roughly 11.3% of GDP. In per capita terms, expenditures are estimated at 4,330 Euros, ranking thirteenth highest in the world, exceeded only by Norway, Netherlands, United States, Switzerland, and Luxembourg.
The German healthcare system is decentralized and managed by the 16 German states. The Federal Ministry of Health provides the regulatory framework under which the 16 German States/Länder operate. Thus, there is no central healthcare region or “capital”; the industry is widely spread throughout the country.
The German healthcare industry has enormous potential to grow and provides excellent opportunities for U.S. medical technology exports that are innovative, patient-centric and user-friendly. Demand is particularly high for e-health and m-health products; chronic disease treatment; mobile technology; orthopedic and prosthetic products and minimally invasive technology; ICU products; ‘smart’ medical products; molecular diagnostics; technical aids; patient safety and hygiene. Germany traditionally imports roughly 30% of its medical technology from the United States.
The Healthcare/Life Sciences (HCT) industry is a priority both for the EU and Germany as reflected in the EU Fund for Regional Development (EFRE)) program 2014-2020 and the German Länder implementation and tendering of this program. Implementation will focus on smart health and aging; the German Government has established councils to pave the way for an integrated and cost-efficient healthcare system. All of this should result in increased opportunities for U.S. suppliers to participate in healthcare infrastructure development projects and partner with German and EU firms and offer export opportunities for U.S. health solutions providers.
The German market for medical devices is regulated by German and European Union (EU) directives, standards, and safety regulations. Companies seeking market entry should 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 direct 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 the arrangement. A representation or distributorship agreement may be harder to arrange, but the German associate will, in fact, purchase the product to be sold, thus sharing the market risk. Licensing and partnering with large corporate partners provides alternatives in times where traditional distributors are bought up by corporates and the market increasingly consolidates.
Since the German market is conservative, U.S. firms should seek to meet some additional criteria to assure product acceptance recognition and marketability when trying to enter the German market. For example, they should supply product information and trade literature in German. At a minimum, catalog inserts should be in German. Firms should also provide operation and instruction manuals in German to assure proper understanding and usage of equipment, as well as providing reliable after-sales servicing and product support or select qualified partners who are capable of providing service and support locally. U.S. firms should maintain close contact and good feedback with partners in Germany in order to stay informed about market developments, trade issues, regulations, and laws concerning their products.
The German market for medical devices is regulated by German and European Union (EU) directives, standards, and safety regulations. The requirements are complex and based on environmental, consumer health, safety and social concerns. Not all standards and regulations are mandatory, but compliance greatly enhances a product’s marketability. Advice on the requirements and compliance certification in the case of a specific product should be sought from the sources referenced below.
The German Medical Products Law (MPG) of 1995 underwent a revision in July 2014. It applies to all equipment, instruments, devices, and materials, which are used on or in the human body and is relevant when trying to get permission to enter the German market. Exceptions are those devices, which achieve their intended effect pharmacologically. About 400,000 different medical products fall under this legislation. The MPG implements EU guidelines covering medical and diagnostic products. Devices complying with the MPG or its equivalent directives in other EU countries must carry the CE mark. They have the advantage of being permitted on the market anywhere in the EU without further certification requirements. The MPG will have to be revised to comply with the new EU Medical Devices Directive, and the new IVD Medical Device Directive, in effect since May 26, 2017. Major changes relate to stricter risk classification, clinical evidence and quality management system rules, post-market surveillance rules, strict responsibilities for supply chain members include importers/distributors, less but more powerful notified bodies, an EU UDI system for device traceability and EUDAMED database for clinical and medical information.
The European Union does not legislate packaging and labeling requirements in general, only in very specific high-risk product related cases. The importer or freight forwarder is the first point of contact for shipping documents and outer packaging/labeling. EU customs legislation only regulates administrative procedures, such as type of certificate and the mention of rule of origin on the customs forms and shipping documents. Product specific packaging and labeling requirements applicable throughout the EU apply to food, medicines, chemicals, pharmaceuticals, and other high-risk items. The purpose of harmonizing such legislation throughout the EU is to minimize the consumer risk.
In Germany, the period allowed for payment is between 30 and 60 days. German businesses are the most reliable payers in Europe, with 83% of payments on time and paid within 24 days. Early payments are credited with a 3% discount, and supplier credits are common. Practices regarding financing, availability of capital, and payment schedules are comparable to those in the United States. Germany has a transparent legal system. There are no restrictions or barriers on the movement of capital, foreign exchange earnings, or dividends. Virtually all major U.S. banks are represented in the German market, principally (but not exclusively) in the city of Frankfurt/Main, Germany’s financial hub. Similarly, a large number of German banks, including some of the partially state-owned regional banks, maintain subsidiaries, branches and/or branch offices in the United States. Germany is not eligible for support from OPIC, TDA or similar agencies.
There is no import duty, only a 19% import turnover tax payable at the port entry. For customs clearance, a product description is required describing the use, origin and value of the product. The cost of the import – turnover tax is usually offset by ultimately passing it on to the end-user in later distribution stages in the form of a Value-Added-Tax (VAT), known in Germany as Mehrwertsteuer (MwSt). The EU TARIC database provides assistance with product classifications.
Demand for medical technologies and supplies will mainly be driven by demographics and a substantial increase in the number of patients. Germany’s population still accounts for 20% of the total population in Western Europe and is increasingly aging. Chronic disease prevalence, a sophisticated healthcare system with highly qualified workers, high healthcare spending, universal healthcare coverage, facilities turning to innovative technologies as revenue-generating optional procedures all herald well for US healthcare exports.
By 2050 the 65 and over age group is forecast to expand to 23 million, up from an estimated 17 million in 2012. The German medical technology industry is a highly innovative and dynamic sector. One third of sales are generated by devices that are less than three years old and approximately 9% of all sales are reinvested in research. The German healthcare system is also among the best in the world regarding the uptake of new technologies. More than two-thirds of German physicians are seeing innovation as the key element in maintaining the high standards of the German healthcare system. Hospitals are allowed to introduce innovative technologies. The German medical device sector, therefore, remains highly attractive for investors and continues to provide excellent potential for U.S. suppliers of innovative and price-competitive products, particularly in high-tech imaging, minimally invasive surgery, big data management, telemedicine, and other key areas. The July 2017 Business Monitor report expects a 5% annual growth rate for the next five years with a positive outlook for the European medical markets, including expansion of the private health segment, upgrade of hospitals and a strong import flow in addition to good local production capabilities. According to BMI, Europe is the most attractive region to commercialize a medical device, with Germany and the UK ranking number 1 and 2, respectively. Germany is a perfect “test lab” for innovative medical devices and technologies as well as a playground for collaborative R&D.
The German market for medical devices is sophisticated and well served. Germany has a handful of large producers, headed by Siemens Healthineers, B.Braun, Fresenius, Paul Hartmann, Draeger, Karl Storz, Otto Bock, and Carl Zeiss Meditec. 92% of the German medical technology industry is characterized by SME companies or sub-groups of larger companies. Almost 1,250 SME businesses (more than 20 employees) employ over 133,000 people and 12,550 smaller businesses employ around 81,000 people. 95% of all companies employ less than 250 employees and rarely does one company represent more than 2% of the entire sector. In addition, foreign industry giants such as Philips (NL), Hitachi (Japan) and Toshiba (Japan) are well entrenched. GE Medical, Medtronic, Agilent, 3M Healthcare, Hollister, Abbott and Johnson &Johnson; Stryker, Zimmer Biomet are only a few of the many German subsidiaries of U.S. medical device suppliers.
As a result of a conservative domestic market, the German medical technology industry has to rely heavily on export markets for continued growth. On average, German medical technology companies export 65% of their products. In 2016 German medical device export sales were up 1.6% to a total of 26 million Euros, with 51% going to other European countries and 19% to North America. Next to a strong German manufacturing base, imports supply around three-quarters of the German medical market U.S. medical device exporters to Germany continue to hold a 27-30% import market share, depending on product and exported goods. U.S. medical technology exports valued 4.1 billion Euros to Germany in 2016.The U.S. is the number 1 exporter to Germany before Switzerland, China and Japan. U.S. suppliers of innovative and price-competitive products especially can compete strongly on the German market.
The current German government has proposed several new health plans to improve and ensure the quality of hospitals, doctor offices and provide the best healthcare to patients of any age group. Since January 1st, 2015, it is mandatory to have an electronic health card which stores personal patient data. The Care Provision Reinforcement Act (Versorgungsstärkungsgesetz) creates incentives for doctors to open their offices in rural areas due to a demographic aging among medical staff and its associated closures of many doctor offices. In addition, the Hospital Structure Act (Krankenhausstrukturgesetz) stipulates that hospitals meet quality standards today and continue to do so in the future. Large scale cost savings and more hospital efficiency are expected.
An e-health initiative was started in 2010 and was transformed into an e-health law in 2016. Its goal is to promote pilot projects to general use and create incentives to set up the necessary infrastructure for telemedicine. As the executive agency for the Federal Health Ministry, gematik has launched the online interoperability directory, called vesta (German language only), where e-health players can register an interoperability standard. Furthermore, digitalization investments for hospitals will continue to receive support from the federal government. Current German Health Minister Jens Spahn is pushing for digitization and an e-health law II. Germany has seen major delays as a result of data safety concerns and disapproval of health professional organizations for cost-sharing.
Interest in, and demand for, innovative technologies is high in Germany. German healthcare players regularly travel to the United States; many doctors have studied in the U.S. or have participated in exchange programs via post docs; there is a natural affinity and many ongoing partnership and collaboration projects. Demand is high fore-health incl. infrastructure, health apps, and security management; minimally invasive, home care/technical aids, orthopedic and implant, and diabetes management technologies as well as oncology diagnostics, molecular diagnostics, personalized medicine and patient management technology/systems.
CE Marking and New Medical Devices Directive and New IVD Directive
On May 26, 2017, the new MDR and IVD Directives took effect. Changes include expansion of the scope of products covered, more rigorous requirements for clinical evaluation, mandatory UDI mechanisms and increased post-market surveillance by EU Notified Bodies. Manufacturers with approved devices on the market will have three years to demonstrate compliance with the new MDR. Exemptions are under negotiation at this time. The competent authority for implementing the EU new medical devices directive is the Federal Health Ministry through BfArm, the executive registration authority, and the Paul-Ehrlich-Institute.
The CE Mark signifies that a product fulfills all necessary EU requirements. CE marking is now a legal requirement for a wide range of equipment manufacturers in Germany. Certification requirements for use of the CE mark vary depending on the product. For some, such as those in the MPG low risk class I, the manufacturers (or importer/authorized representative, if the product is manufactured outside the EU) may self-certify compliance with EU requirements and affix the mark; for others, the certification of a “notified body” (an accredited certification agency such as the TUEV – Technical Inspection Agency) will be required. For the medical aids sector, the workability and safety of a product is now considered satisfied by CE marking. The CE mark is a visible indication that the manufacturer signed a “Declaration of Conformity” prior to affixing the CE mark, claiming compliance with all relevant CE marking directives in force.
All electro-medical equipment in Germany must be suitable for use with 220 Volt, 50 cycle electrical current, and should have VDE or TUEV approval. A UL approval is not a substitute but is helpful to obtain “GS/VDE”, or GS/TUEV” approval in Germany. “GS” stands for “gepruefte Sicherheit” (safety tested). Although “GS” and the “VDE” (or “GS and TUV”) marks are not required by law, they are highly recommended for marketing electro-medical goods in Germany. These labels denote high product safety; German consumers look for these labels as Americans do for the “UL” mark.
The U.S. Product Safety Testing Institute, Underwriters Laboratories (UL), the VDE Testing and Certification Institute, and the TUEV Product Service, have formed a strategic alliance for testing of electromagnetic compatibility (EMC) which has resulted in globally recognized EMC test mark. For manufacturers of electrical and electronic products, this cooperation has led to a substantive simplification of EMC testing. Through a single test carried out by one of these three partners, a product can now be awarded an international EMC mark, which replaces the national test marks in the major world markets of Europe, the USA and Japan.
To place a medical device on the market, a manufacturer, authorized representative, reseller or distributor must observe all relevant legislation. A list of notified bodies can be downloaded from the EU Commission website. Their number has meanwhile decreased from 70 to around 50, and is expected to consolidate further with the new MDR and IVD Directive requirements.
For the reimbursement of innovative medical devices it is crucial whether the device will be used in the hospital (inpatient) or ambulatory (outpatient) setting. In the inpatient setting, new medical services are reimbursed without prior assessment, as long as fundamental principles of quality and cost-effectiveness are not violated. In the inpatient sector billing of services is based on DRGs, a fee per case system. There are roughly 1,200 different DRGs in Germany. The DRG classification system uses case-related coding rules which apply to diagnoses (ICD-10 German modification) and procedures (Operations and Procedure Codes-OPS). With the DRG case-based flat rate, all costs related to the inpatient diagnosis/treatment is covered including medical devices. The DRG system is revised annually by InEK-Institute for the Remuneration System in Hospitals. The amount of each DRG compensation is based on data collected continuously from several hundred German clinics.
The new medical device is reimbursed immediately if it is part of an established method which has been implemented already in the reimbursement system. For innovative devices and technologies not yet in the system, pathways such as the NUB (novel diagnosis and treatment methods) procedure should be explored, particularly when the device is significantly more expensive than current methods. For a more detailed description of NUB methods and timelines, please contact the country specialist listed further below.
Outpatient services are mostly provided by private practitioners, around 148,000, which by law, are members of their regional Statutory Health Insurance (SHI) accredited physicians association (ASHIP). The physicians are paid by their respective ASHIP who in turn is paid by the public insurance funds. ASHIP funds pay their members on the basis of a uniform evaluation scale known as EBM (Evidenced-Based Medicine). Physicians are only able to invoice services that appear on the EBM. The EBM is set by a committee of SHI representatives and ASHIP representatives, called Evaluation Committee (in German: Bewertungsausschuss). The payment scheme for outpatient physicians is based upon a mix of services delivered, number of patients served, and fixed budget distribution system. Any novel diagnostic/therapeutic device/procedure must be evaluated before being reimbursed. Only procedures which “show a benefit, are medically necessary and efficient” can be reimbursed. The decision on reimbursement has to be ratified by the Federal Joint Committee, which may request a Health Technology Assessment (HTA) by the Institute for Quality and Efficiency in Healthcare (IQWIG). The actual payment amount of an EBM-listed procedure is the responsibility of the Evaluation Committee. In case of an approval, the medical service/device must be covered by SHI and will then be reimbursed throughout Germany by all SDI insurance funds. U.S. companies interested in filing for reimbursement are almost certain to need a local partner for the process. Country specialist can provide a list of resources upon request.
Firms exporting medical devices to Germany will not encounter any direct trade barriers or quotas. Non-tariff, indirect trade barriers could include the complex German reimbursement system and the need for additional registration procedures in the case of medical assistive technologies or products sold in pharmacies, with the requirement to apply for HMV or PZN codes, respectively. For Class 2 medical products, the German medical products law requires manufacturing and distribution control/quality documentation. The new EU Medical Devices Directive (in addition to Brexit) will result in a shortage of notified bodies contains insufficiently tight transition periods and will result in substantively higher expenditures and costs for clinical evaluations of medical products, according to the German Advanced Technology Association, BVMED. In addition, the new MedTech evaluation procedure according to §137h SGB V (German Social Law), in effect since Fall 2016, changes the established annual applications of hospitals for first-time, high-risk, especially invasive NUBs with DRG Institute InEK considerably. BVMED has published guidance on new NUB procedures, in German. BVMED’s Olaf Winkler (email: firstname.lastname@example.org) is a contact for further questions.
Procurement & Tenders
Legal basis can either be the national ‘domestic public procurement law’ or the standardized EU public procurement law as per §§97ff. GWG. The national public procurement law serves only to ensure as economical a purchase of services as possible by the (public) payer. The EU public procurement law aims to ensure standardized access for companies in all EU member states to procurement markets within the EU. The legal basis is outlined in the EU Procurement Law. However, the requirements of the EU procurement law, compared to the national procurement law, are more formal. Nevertheless, the EU procurement law – different from the national procurement law – offers the bidders effective legal protection and therefore an instrument that allows for an official legal review of the correctness of the procurement process and decision and, if necessary, to have another check carried out by the courts. The purely national procurement law does not offer this option. An essential criterion of demarcation is the exceedance of a standard value. In the area of delivery and services, which have to be put out to tender according to standard official contracting terms, this amount is 206,000 Euros. Only when the net total order value over the entire duration exceeds this value does the EU procurement law apply. A prerequisite for the intervention by the EU public procurement law regime is “A public employer issues a public tender with a net order value above the threshold where no obvious exceptions apply.” The obligation to tender according to the EU public procurement law is therefore aimed at public hospital operators such as communal hospitals, university hospitals, other public hospitals, such as those partly funded by trade associations, and the respective pooling agreements, for instance in the form of purchasing associations. The European Tender database is: http://ted.europa.eu
Hospital Tenders in Germany if below the 200,000 Euro threshold, are published in:
The National Information platform, www.medizintechnologie.de publishes health-related federal funding projects. It is a result of the Federal Government’s national strategy process “Innovation in Healthcare” involving the Economics, Health, and Science Ministries and aims at making German healthcare more competitive, strengthening patient care, health system performance and innovation in MedTech research. This also involves funding of German delegations to the U.S., such as a July 2017 e-health delegation to Philadelphia and New York.
A good summary of health insurance options in Germany can be found here: http://www.howtogermany.com/pages/healthinsurance.html. A more detailed overview, with historical track, is available as a booklet here: http://german-health-care-system.com/
September 26-29, 2018 – Düsseldorf, Germany
REHACARE International is Europe's premier rehabilitation and care event. It is open to the public and has 51,250 visitors and 902 exhibitors from 36 countries. US exporters of rehabilitation and/or personal care equipment should consider exhibiting at or attending REHACARE. There is no USA Pavilion and interested U.S. companies should book individual exhibit space.
MEDICA with Compamed
November 12-15, 2018 – Düsseldorf, Germany
www.medica.de / www.compamed-tradefair.com
Considered the world's most important and largest international fair for medical equipment, the annual MEDICA draws 129,000 trade visitors from more than 70 countries. Over 4,800 exhibitors from 67 foreign countries exhibit at the show. Parallel to Medica, Compamed will take place as the marketplace for suppliers to the medical manufacturing industry, with 728 exhibitors from 37 countries. The show offers two USA Pavilions in the Diagnostics and Medical Product Halls plus the USDOC-organized USA CEO Center as meeting space on the show floor. Special offer for U.S. companies includes a Personal Assistant for Appointment-Setting; Pre-show Promotion; International Delegations/USA Reception; and In-Depth Introduction to the International Medical Markets through Showtime program. For more information contact Anette.Salama@trade.gov.
38th IDS-International Dental Show
March 12-16, 2019 (biennial) - Cologne, Germany
IDS is the world’s leading trade show and sector meeting place for decision-makers from dental practices, dental labs, the specialist dental trade, and the dental industry. Over 2,200 exhibitors from 56 countries display their products and technologies to over 138,000 visitors from 151 countries. IDS offers a large Dental Trade Alliance organized USA Pavilion, which is supported by the US Commercial Service. For more information contact: Uta.Kirst@trade.gov
April 4-9, 2019 – Cologne, Germany
FIBO is the world’s leading trade show for fitness, wellness, and health. More than 700 exhibitors from 40 countries and more than 138,000 visitors attend FIBO every year. Approximately 25-30 US companies participate in thematic halls for sports nutrition, nutritional supplements, sports equipment, health and wellness equipment, and service providers. FIBO offers a USA Pavilion organized by Kallman Associates and supported by the US Commercial Service.
DMEA, formerly conhIT 2019
April 9-11, 2019 – Berlin, Germany
conhIT has been renamed DMEA. Connecting Digital Health and is Germany’s major annual health event, bringing together over 500 exhibitors from 19 countries and close to 10,000 visitors in five exhibit halls on the Berlin fairgrounds. All major US digital health players including Microsoft, Cisco, GE, EPIC, Intersystems and some smaller niche market players participate. Different zones are available for exhibits such as mobile health zone, app zone and workshops throughout with speaker opportunities. For more information contact: Uta.Kirst@trade.gov
A+A 2019 (Safety + Health at the Workplace)
November 15-19, 2019 – Düsseldorf, Germany
With over 63,000 visitors and over 1,600 exhibitors A+A is the world's largest and most important specialist trade fair for all aspects of safety and security. Core products/technologies of A+A are safety, security, and corporate health management including prevention and therapy of work-related illnesses.
November, 2019 – TBA
The 22nd Bio-Europe event will be the largest biotechnology partnering conference held in Europe. More than 3,000 global decision makers from biotechnology, pharma and finance annually attend BIO-Europe to identify new business opportunities and develop strategic partnerships. BIO-Europe features the industry’s most advanced web-based partnering system enabling delegates from all parts of the biotechnology value chain to quickly identify, engage, and enter into strategic relationships that drive their business successfully forward. Special offers to international visitors include International Delegations Reception and In-Depth Introduction to the German Biotech Market. For more information contact
OTWorld (formerly, Orthopädie + Reha-Technik)
May 12-15, 2020 (biennial) - Leipzig, Germany
The orthopedic and rehabilitation industry's leading event worldwide with 548 exhibitors and over 20,400 international visitors. The event takes place every two years and combines the presentation of innovative technology and new products with professional training of the highest quality. In 2013 the event was re-named OTWorld, since the show is truly international in scope. The traditional USA Pavilion is organized by Kallman Associates and supported by the US Commercial Service.
Local Trade Associations
BVMED – The German Medical Technology Association
ZVEI Health Pages – German Electrical and Eletronic Manufactures’ Association
Spectaris – German Hightech Industry Association
DKGEV – The German Hospital Federation
BVITG – Fedeal Assocation for HealthIT
BiM – Federal Association for Internet-Based Medicine
VDDI – Association of the German Dental Industry
BIO Germany – German Biotechnology Association
Federal Ministry of Health
Federal Ministry of Education and Research
Federal Institute for Drugs and Medical Devices (Competent Authority)
Healthcare Procurement and Tenders
Private provider for tender information
Government Health Plans:
International Federation of Health Plans
Association of Public Health Plan Providers
1. Is the CE mark enough to export a medical device to Germany?
Yes, in principal. The German representative, or importer/distributor will need to notify and register with the local state health authority at port of entry, when first placing the product onto market. It is a registration not an approval. It is very important that the device is registered otherwise it may not enter the country. The registration can be done either by the manufacturer or the distributor. In any case the device registration is in the name of the manufacturer even if the administrative paperwork is submitted by the distributor
2. What is the custom import health clearance?
All medical devices entering the German market will be checked at customs, which will issue an import health and safety clearance. To obtain the clearance the following documents are required: Declaration of Conformity, CE certificate, Registration Number from the German Medical Device Registry, Product labeling (as required in the EU directive): CE marking, European Authorized Representative, Serial number/lot number, Lot numbers: all lot numbers need to be reported, preferably on the invoice but if this is not possible on the bill of entry.
3. What are the major sales channels in Germany?
This depends on whether medical products target the hospital/in-patient or outpatient/ambulatory markets. For the hospital market, a German representative or distributor partner who has experience with the Group Purchasing Organizations, and/or has an established hospital customer base is preferable. The out-patient segment is served via distributor partners and, since Germany is a very decentralized large market, can be divided into regions, with two to three distributors in place. For capital equipment and large equipment providers, it is always preferable to have a direct presence with an office in Germany.
4. How do I get my product on the list of reimbursable products?
In the in-patient segment, there are two pathways for a reimbursement – 1. Application of a new method (in German, NUB) or 2. Application for an Operation-and- procedure (OPS) code. Both ways have their pros and cons and it depends on the product or method, the price, the strategy, etc. which one is most suitable. NUB applications take about 10-12 months, 3-4 months for the application and 6 months for negotiations with the sickness funds.
The second pathway takes 3 years. The first year for the application and two years of collecting financial data in the hospitals.
In the out-patient segment, assistive technology and rehabilitation products are recommended to be registered in the German Technical Aids Registry (HMV=Hilfsmittelverzeichnis) to get on the list of reimbursable products with the sickness funds. It is not a legal requirement for a product to have a code assigned to it to be eligible for reimbursement, but it is good for logistical reasons and so that the patient does not have to negotiate individually with his sickness fund for reimbursement. The codes are assigned according to product group and subcategories, with the final four digits identifying the supplier/manufacturer. Some of these products have fixed maximum reimbursement prices attached to them. Since all application forms are in German, it is recommended to use a German partner for the application process. The applicant who submits the application for the code will have the "rights" to control the reimbursement. Some US companies have been burned by having an agent/rep/distributor do this in their own name and have had to take recourse to get this reversed. U.S. suppliers should make sure that the medical device is registered in their name.
U.S. Commercial Service Contact Information
Name: Anette Salama
Position: Senior Commercial Specialist, Healthcare/Life Sciences
Phone: +49 211 737 767 60
Healthcare spending (including investment)
... as percent of GDP
... of which spent on inpatient services (including long-term care)
... of which spent on pharmaceuticals/consumables
... of which spent on investments
… of which spent on outpatient services
… of which spent on administration
... of which spent on other
Hospitals, Procedures, Healthcare Professionals
Number of hospitals
Number of hospital beds
... available beds per capita
...of which in public hospitals
…of which in charitable hospitals
...of which in private hospitals
Number of surgical procedures
...of which intestinal
...of which muscular-skeletal
...of which are surgeons
...of which are internal medicine
...of which are pediatricians
Life expectancy men/women
Men: 78.4 years; Women: 83.2 years
Percent of population older than 65
...caused by cardiovascular diseases
...caused by cancer
Prevalence of Diabetes
9.3% of population in 2012 (+49% over 2000)
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