The medical technology and devices market of Europe is wide and varied, it accounted for a total sales of over US$ 84.66432 billion in 2006. Being one of the highest production growth rates sector, the medical technology and devices industry comprises 11,000 companies and employs over 435,000 people across the continent.The European Union (EU)
The European Union (EU) is a political and economic community of 27 member states, with the purpose of developing one market to enable freedom of movement of people, services, goods, and capital between member countries. Economically significant and home to 492 million people, the European Union (EU) generated about $15.7 trillion as GDP in 2007.
There are great differences among EU member vis-a-vis economic development that are expected to continue. At the same time while this diversity poses challenges for the medical instrument
/devices industry, it also presents it with ample opportunities of growth.EU Medical Device Industry Overview
The annual growth rate of the medical devices market in France, Germany, Italy, Spain, and the UK is close to 9 percent, whereas the market value is estimated at $51 billion.
The most promising medical device market segments within the region pertain to neurology, cardiovascular devices, imaging, in vitro diagnostics, general surgery, orthopedics, ophthalmic equipment
, urology, and respiratory devices.
Europe's medical technology industry is vibrant with a lot of investment going into R&D services. In 2006 about $5.05 billion were spent on R&D. The major European exporting countries of medical technology, and their contributions are Germany ($18.6 billion), Ireland ($8.76 billion), France ($8.1 billion), and the UK ($7.4 billion). In addition Germany, Ireland, the UK, Denmark, Sweden and Finland are said to have medical technology trade surpluses.
Medical Device RegulationMedical devices within Europe are regulated under the following directives
- In Vitro Diagnostic Devices (IVDD) – This regulates all diagnostic devices and supplies that are used away from the patient.
- Active Implantable Medical Devices (AIMD) – This directive covers all active devices and accessories meant to be permanently implanted in patients.
- The Medical Devices Directive (MDD) – This directive controls all other general medical devices not covered by the above directives.
The directives have been subjected to amendments overtime and some recently proposed amendments pertain to conformity assessment (viz. design documentation, etc.), post market surveillance, requirements, compliance of custom-made device manufacturers and original medical device directives.Medical Technology Growth DriversThe following factors are expected to drive the growth within the European medical device markets
- Europe has a large population and an aging population. In addition the population in the region has also increased due to an influx of migrant workers. According to projections the percentage of seniors 65 and over will rise from 15.4 percent in 1995 to 22.4 percent by 2025, within the EU.
- The region comprises several vibrant economies with high levels of health care spending as a proportion of GDP.
- Due to the high standards of health care there are good prospects for the latest health care technology products and devices. Increasing health care standards have led to an overall death rate to decrease by 25 percent, and and increase of 4.3 percent in life expectancy from birth.
The fact that Western Europe alone made up for market of over 403 million people and a GDP of $18.1 trillion in 2008, trade opportunities within the continent are encouraging.