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Opportunities for US Medical Device Firms in the European Union
December 29, 2016 - By: - In: Medical Device Translation - Comments Off on Opportunities for US Medical Device Firms in the European Union

While the United States is currently the largest market for medical devices, the European Union presents significant opportunities for US medical device firms looking to expand abroad. The European Union’s medical device market represents the second largest in the world; it’s worth 100 billion euros and accounts for 31% of the entire globe’s medical device market. (To compare, the US accounts for 40%.)

A few of the reasons the European Union is an attractive place to expand are that it has a large population, it spends a significant amount on health care and medical devices, and it offers a unified regulatory framework.

The European Union is a political and economic union currently composed of 28 member states: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.

With a population of 510 million, the European Union currently spends 10.4% of its gross domestic product on health care, or 2,645 euros per capita. That includes 195 euros per capita on medical devices (and 450 euros per capita on pharmaceuticals). To compare, the US spends 380 euros per capita on medical devices, and Switzerland, Australia and Canada are currently the only other countries besides the US and EU countries with significant levels of health care spending.

The European Union has a relatively low birth rate coupled with high life expectancy, leading to a population that is increasingly skewing older and will be looking to more medical devices to improve their quality of life.

Fortunately for US medical device firms, selling medical devices in Europe is easier than ever. While the European Union is made up of 28 countries, gaining permission from each individual country to sell a medical device there is not required; instead, the regulatory approval process has been unified.

To gain access to the single EU market, your firm’s medical device will need a CE mark. This certification guarantees that a medical device meets all of the requirements set by the European Union’s Directive on Medical Devices.

Part of the requirements, however, is that the medical device’s patient information be translated into the official language(s) used in each EU country you want to sell the medical device in.

Need More Information?

Translating your medical device’s patient information can help you sell to new markets in the European Union.

For more information or to discuss your specific requirements, please get in touch at 212-355-4455 ext 208 or

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