Medical Device Industry in Germany

The German medical device market is the largest in Europe and the third largest in the world. It was valued at $26 billion in 2014 and continues to grow. Some of the best-known medical device manufacturers are based in Germany, and some major players from around the world have operations in Germany. However, small- to mid-sized medical device companies make up the majority of the industry.

Opportunities in the German market

Germany is an attractive market due to its consistent growth and sophisticated approach to healthcare. The healthcare industry is receptive to new, innovative technologies to maintain a high level of care for Germany’s aging demographic, which makes up more than 20% of the population. Demand for highly innovative technologies and diagnostic, therapeutic and minimally invasive equipment remains high. Many German manufacturers export their products, leaving an opportunity for foreign importers to capitalize on these demands.

Industry challenges in Germany

Germany is a major player in the global medical device market, in terms of market reach and innovation, but the domestic market lagged behind other major European markets in recent years. German manufacturers export their products to other markets to maintain growth. Importers will also face competition from major global device manufacturers that are well established in the German market.

Translation Considerations

Medical device manufacturers provide Instructions for Use (IFU) with each medical device to inform users of proper use and of any required safety precautions. These documents can also be referred to as Directions for Use (DFU). BS EN ISO 15223-1:2012  specifies symbols to be used in medical devices IFUs to simplify labeling and ensure consistent use of symbols in all member countries. The use of standard labeling also helps reduce translation costs by reducing the number of words required to convey the intended information. This is an important factor considering the EU has 24 official and working languages.

The meaning of most of the ISO 15223-1:2012 symbols is self-evident. Some are already in widespread use and are familiar to healthcare professionals. The meaning of others will become clear with use or when viewed in the context of the device itself. Symbols used with medical devices for use by other than healthcare professionals can require additional explanations.

Welocalize Life Sciences is an ISO 9001, ISO 13485, and ISO 17100 certified language services company that specializes in translation for medical device companies. We provide professional translation of IFUs in over 175 languages.

Contact Welocalize Life Sciences for information on how we can help with translation of CE Marks, IFUs and other regulated materials.