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Business & Profession Professional Development, Business and Innovation

The CE Mark: A Medical Device’s Passport To A Multibillion Euro Market

At a Glance

  • The EU is the second largest market in the world for medical devices, which in 2007 was worth more than €72.6 billion
  • To be marketed in Europe, a device needs to meet safety requirements and attach a CE mark
  • Depending on the type of product, the CE-marking process can range from self-certification to a rigorous external audit
  • A regulatory plan will therefore help you anticipate the requirements and get your innovation its “passport” for European sales

There’s no denying that developing a new medical device is a huge undertaking. Once your device is created, has proven effective in clinical trials, and you’ve secured financing, you might be forgiven for feeling like the end is in sight – it’s not. To sell a product in any country, it must meet its regulatory standards. In Europe, this means the Conformité Européenne (CE) mark: all European Union (EU) member states and countries within the European Economic Area (EEA) require it. In 2007, sales of global medical devices and diagnostic products were €219 billion, with EU sales of €72.6 billion accounting for just over a third of that (1), making it the world’s second largest market for these products. Knowing when you need a CE mark and how to get one will help you enter this lucrative marketplace as quickly and easily as possible.

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