Experts for Medical Devices
NEMIUS

Your ticket to Europe

For more than ten years, NEMIUS, based in Germany, has been advising manufacturers on the approval of medical devices and in-vitro diagnostics in Europe and beyond. We know the market and are happy to support you in your project. NEMIUS also offers you the possibility to sell your products on the European markets in an uncomplicated way as an EC-REP.

Your ticket to Europe

Why Europe?

27 countries, one economic area! The European Union (EU) is one of the largest sales markets in the world with 450 million people living there. Hence a huge number of possible customers! Learn more about the EU and its potential in 30 seconds.

What we can do for you

According to Article 11 of the European Medical Device Regulations (EU) 2017/745 (MDR) or (EU) 2017/746 for In-Vitro Diagnostics (IVDR) as a manufacturer from outside the European Union (EU) you need an authorised representative (EC-REP) in order to legally place your products on the European markets. We at NEMIUS Medical offer to take on this role of EC-REP for you, thus providing access to the European markets.

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What we can do for you

Further services

For the many other challenges in the complex world of medical devices and in-vitro diagnostics – may it be an update on your Quality Management System according to the updated regulations, training for your employees at key points in your company, or consulting in dealings with the EUDAMED registrations etc. – we offer you our professional expertise. Our consultants are at your side with a broad range of experience and know-how from the entire medical device sector.

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Further services
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