The 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.

  • Regulatory bodies. The German market for medical devices is regulated by German and EU directives, standards and safety regulations. According to the US International Trade Administration, the requirements are complex and based on environmental, consumer health, safety and social concerns. Not all standards are mandatory, but compliance greatly enhances a product’s marketability. Find advice on the requirements and compliance certification at the German Medical Devices Act (MPG) of 1994, which was amended in August 2015.
  • 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. (Source: USTA)
  • 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.

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