What is a European Authorized Representative (EU MDR 2017|745)

What is a European Authorized Representative or EC Rep or CE Representative? (EU Medical Device Regulation MDR 2017/745)

This is an important topic for the Medical Device Industry.

There are many names for this Economic Operator that is required if you are a Medical Device Manufacturer located outside of the European Union.

Learn within this video who can be an EC Rep and what are its responsibility. You'll see that after that you'll maybe not want to become an EC Rep.

Is it enough to have an Authorised Representative to sell your medical devices in Europe? No, there are still some economic operators that you need. Let's see together which one it is.

It's also important to know why your distributor is not the right choice for being your EC Rep. Yes, I know that it would be easier for you to have 1 entity to do both but you'll see that there will be a lot of risks.

On my Article "Top 11 questions about the European Authorized Representative I inform you about how to choose one and also about the Brexit. Because all the E.A.R. located in the UK will lose this qualification as the UK is leaving the European Union. But maybe they'll be on the EFTA as Switzerland.

I hope this video helps you to understand more about this Economic Operator role.

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Links from the Video

- Resource page:
- Top 11 questions on the E.A.R:
- Free Mini-Course EU MDR 2017/745:

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