Medical Devices in Germany
Germany is the third biggest market for medical devices in the world and the largest in Europe by a long way. It is roughly twice the size of the French market and three times the size of both the British and Italian markets (2016 Top Markets Report Medical Devices). German annual expenditures on medical devices and technologies amount to about €28 billion and employs 190,000 people in Germany (source: Healthcare Expenditure Report 2012 of the Federal Statistical Office, April 2014).
Ranking only behind the USA and Japanese markets in terms of size, the German market is predicted to grow at a €CAGR of 5.5% between 2014 and 2019. This should see the market expand from US$26.3 billion to US$30.8bn by 2019.
In Germany it is the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, “BfArM”) that classifies a product as a medicinal product or medical device. Medical devices are regulated and defined by the German Act on Medical Devices (Medizinproduktegesetz, “MPG”).
In Germany, a medical device is defined as a device which fulfil its action by physical means (including mechanical action, physical barrier, replacement of, or support to, organs or body functions). A device may be assisted in their function by pharmacological, immunological or metabolic means, however any device achieving its principal intended function by such means would be classed as a medicinal product. If the product is intended to administer a medicinal product or which incorporate a medicinal product it may still be classified as a medical device.
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