The medical technology (medtech) sector is a market which is growing dynamically worldwide. An aging population combined with the need for new and innovative medical technology sustain the sector’s strength and constant growth, despite the current economic situation. Today, Germany is Europe’s leading location for medical technology and 3rd biggest medical technology producer and medical services provider worldwide. In terms of new patent registrations German manufacturers rank second behind teh USA, making Germany Europe’s strongest location for innovation in this industry.
The broad spectrum of technologies available in this area ranges from electrical engineering/electronics to precision mechanics and optics. Furthermore, technologies from the textile industry, the plastics processing, pharmaceutical and, most recently, from the biotechnology industries are also utilized in German medical products.
Industry in Numbers
- Total industry turnover of EUR 18.3 billion in 2009
- Around 9% of the total turnover was reinvested in R&D
- In 2010 exports increased by 6% in the EU member states, 19% in rest of Europe, almost 13% in North America, more than 26% in Asia and over 28% in Middle and South America
- With 87,000 employees the number of workers remained constant; 15% of all employees in this industry work in R&D
- The industry is characterized by small and medium-sized enterprises. 95% of all companies employ less than 500 people.
Germany is the largest market for medical devices in Europe and the third-largest in the world. Nowadays, the medtech industry is considered to have the highest growth potential. According to a recent survey from the Medical Technology Association, (BVMed), 46 percent of the surveyed medtech companies expect a rise in revenues in 2010. In comparison to last year, businesses in the field are being more careful about their expectations, but have confidence in the sector’s stability.
Foreign exporters must be aware that, in order to place medical devices on the market for the first time, the products must be registered with the appropriate competent authorities. In general, the manufacturer or authorized representative is responsible for the introduction of new medical devices on the market. The medical device’s importer is responsible in cases where the manufacturer’s location is outside the European Union and an authorized representative in the EU has not been designated. The Federal Institute for Drugs and Medical Devices (BfArM) offers detailed information on the EU directives on medical devices as well as guidance in accessing the German medical device market and the prerequisites to be fulfilled. Furthermore, a list of notified bodies can be found on the German Institute of Medical Documentation and Information’s website (DIMDI). This site offers access to about 60 databases with approximately 100 million documents.
Manufacturers and importers of medical products must also make sure that their products comply with the REACH regulations (Registration, Evaluation and Authorization of Chemicals). According to REACH, companies are required to prepare information on the chemical substances used in their products and register the data with the European Chemicals Agency (ECHA). Registration is required for most hazardous substances above 1 ton per year, for substances toxic to the aquatic environment above 100 tons per year, or substances manufactured or imported above 1.000 tons per year. For many medical products compliance with REACH is a prerequisite for affixing the CE marking.
All medical devices intended for the German market must bear a CE marking before they can be sold or installed. The CE marking is a mandatory conformity mark attached to certain products intended for sale within the European Union which indicates conformity with the essential health and safety requirements set out in the applicable European directives. Depending on the type of product, conformity can be assessed either by the manufacturer himself or by an authorized office.
Foreign manufacturers of medical devices tend to enter the German market by setting up subsidiaries. It is also possible to enter the market by contracting with a specialized importer in the medical device field or by participating in the tender procedures of hospitals or clinics. Another way of finding business partners in Germany is by participating in specialized trade fairs. The Association of the German Trade Fair Industry, (AUMA), offers a search engine on its website where interested companies can find trade fairs in their business sector.
Institutions in the German medical devices industry can be of great help in finding ways of effectively introducing products to the market. The German Medical Technology Association, (BVMed), for example, represents about 230 manufacturers and service providers of medical devices. As a trade association, BVMed promotes and represents the combined interests of the medical technology industry and trade companies. Users can download several documents, e.g. the BVMed Annual Report which expands on the medtech market in Germany.
The Trade Association Medical Technology, (SPECTARIS), represents the interests of around 400 mostly small and medium-sized companies in the medical technology goods and appliances sector. The Trade Association Medical Technology provides its members support with and information on different industry-related areas and topics.
The German Association of Biomedical Engineering, (DGBMT), works to promote the development and application of innovative medical technologies. In the DGBMT, Physicians, scientists and engineers combine their efforts to facilitate the use of advanced technologies for diagnostics and therapy. The DGBMT organizes initiatives, projects and events to support promising activities like micro- and nanotechnologies in medicine and life sciences.
Hospimed publishes information databases on manufacturers and suppliers in the German health service sector in print, on CD-ROM and online.
Eucomed is the voice of the medical technology industry in Europe. The alliance represents around 22,500 European designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium-sized companies account for more than 80% of the businesses in this sector. Eucomed is active in market data collection, research and innovation projects as well as in international trade issues.