Spotlight #1 – access to european market

SPOTLIGHT, insights on the medtech world
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Have you ever considered selling your products in Europe? With over 500 million people, it's one of the biggest and most important markets in the world. So far so good, but have you had the chance to directly liaise with one of the numerous authoritative bodies? One of the big downsides of the European market is its overwhelming size. With 28 member countries and 24 official languages, companies who are not familiar with the mechanisms can easily get lost. This is especially true for regulatory affairs and all that comes with it.

The role of an Authorized Representative is defined by the applicable European medical device legislation. It's a prerequisite for CE-Marking, and thus selling your products in the EU, that you have an EU Authorized Representative from an EU Member State appointed for your company. An Authorized Representative also plays a key role in paving the way to market your devices in Europe.
 
European authorities and numerous other entities will only correspond and communicate with an authorized address located within one of the EU member states. The Authorized Representative therefore has an essential role when it comes to CE-registration of medical devices, incident reporting, post market surveillance, product recalls, etc.
 
Are you interested or do you require further details? If so, please get in touch.

Written by Michael Sander
mdi Europa, MD101 Partner

 

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