Port Surface Inspection | © pfm - Produkte für die Medizin AG / BVMed Bilderpool
Our Technologies Save Lives - Both Here and Around the World
Germany is Europe’s leading business location for medical technology. The medium-sized enterprise dominated sector has also maintained results – despite the international recession. In terms of new patent registrations, German manufacturers currently lie second behind the USA, making Germany Europe’s strongest location for innovation in this industry. We have the trained professionals, and the potential for growth that has made many global medical device manufacturers choose to make Germany their home.
Fact Sheet: Medical Technology Cluster in Germany | © GTAI
Medical Technology Clusters in Germany
The publication provides a countrywide overview of more than 30 specialized medical technology clusters. Germany's clusters provide benefits along the entire value chain. More
|THE GERMAN MEDICAL TECHNOLOGY INDUSTRY IN NUMBERS (2012)|
|Sales||27 bn (2012)|
4.3% increase in 2012
Lead market in Europe
66% (15.1 bn) of the production are exported, 7% increase in 2012. Target markets:
- European Union 37%
- Europe (non-EU) 15%
- North America 19%
- Asia 18%
- ROW: 12%
|R&D Expenditure||9% of annual turnover in 2012|
|Employees||170.000; 15% in R&D|
|Companies||Structure: approx. 1.200 companies, dominated by SME’s|
The German medical technology industry generates one third of its turnover from products less than three years old. However, this is only one indicator for the high level of Germany’s innovative strength. In terms of all European patent applications made in 2012, Germany holds a share of around 18 percent of the 148,494 patent applications registered at the European Patent Office (EPO). With 10,412 patent applications in 2012, the medical technology sector is leading Germany’s sectors from the front. From a global perspective, Germany was second only to the US in terms of number of medical technology patent applications in 2012.
Research and Product Development
The approximately 1,200 companies (each with more than 20 employees) active in the medical technology sector invest around nine percent of their turnover in R&D. Close cooperation between Germany’s R&D institutes and equipment manufacturers, not to mention a plethora of in-house R&D facilities, helps to maintain an internationally unparalleled competitive edge. R&D is considered to be among the most important areas for the development of the German economy. R&D projects can count on numerous types of financial support in the form of grants, interest-reduced loans, and special partnership programs, some especially created for small and medium-sized enterprises (SMEs). Many collaborative projects are coordinated medical technology cluster organisations with centralized management and project management staff.
Market access: CE Marking and Reimbursement
Mandatory Conformity Marking
Any medical device intended for the German market must bear a CE marking before it can be sold or put into service. The CE marking is affixed to certain products intended for sale within the European Economic Area (EEA) to indicate conformity with the essential health and safety requirements set out in European directives. CE marking is the declaration by the manufacturer (and acceptance by an assessment body) that a product complies with relevant directives. The fulfillment of all legal requirements is determined in a formal conformity assessment procedure called the Medizinproduktegesetz (MPG – “Law on Medical Devices”).
Secure and sustainable market demand offers excellent sales opportunities for medical device manufacturers and service providers. The fixed lump sums of the German diagnosis-related group (DRG) system with 1,187 individual DRGs make the hospital market transparent. Costs and frequencies of all diagnosis and therapies are accessible via the public InEK (Institute for the Hospital Remuneration System) G-DRG database report browser. With 244 individual hospitals, a representative sample of more than two thousand German hospitals provide individual data to InEK. InEK concentrates DRG system management functions on behalf of Germany’s major health insurance associations and the German Hospital Association.
Medical products that do not substantially differ from available products are likely to be included in the system. This means they will be available for regular purchase by hospitals and purchasing groups with the reimbursement of individual procedures and equipment in place. The German DRG system provides operations and procedures (OPS - Operationen- und Prozedurenschlüssel) codes to classify reimbursed procedures as part of a national version of the ICPM (International Classification of Procedures in Medicine) system. In the case of innovative products that do differ significantly from the current state of the art or have no comparable alternatives, a new OPS code needs to be established for reimbursement purposes. Novel diagnosis and treatment procedures (NUB - Neue Untersuchungs- und Behandlungsmethoden) can be introduced to the DRG system via an NUB application which should be submitted by a hospital claiming the need for the innovative product.
Different covers of GTAI brochures | © GTAI
Interested in general guides about the German business location? This section gets you started: