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

[@EasyMedicalDevice]

Hi Everyone, I hope you enjoy this video. If possible I want to you tell me one question that you still have on the European Authorized Representative. This would help me to update my article mentioned in the video. And maybe I will change the title to Top 12 or Top 13 questions about the European Authorized Representative. Thanks for your support. Really appreciated.

[@usuariousuariousuario]

Hi! Very great and objective content! Congratulations! One question: In case the importer is bringing a product from a non-EU country, BUT, it's for his own use or the use of his company: Can this importer be appointed an EAR and under the agreement become responsible for the conformity assessment, for affixing the CE marking and so forth? In other words, is the EAR mandatorily meant to act as a contact point for companies selling products to EU consumers? Or the EAR can also be the one who will "put the product on service"?

[@treythorsen225]

Hi Monir. Great video! This is very informative. You mentioned importers in the beginning of the video. Did the MDD have a requirement for importers? Is the new per the MDR? Can your Authorized Rep be your importer?

[@EasyMedicalDevice]

Thanks Trey, MDD had no specific requirements on Importer. The economic operator part of MDR is now more precise on the role of each actors. Yes your Authorized Rep can be your importer but you have to be careful. It’s better to separate then in case you have an issue that happen or if because of this they decide to increase prices and you have no choice but accept it.

[@purnisam5970]

Hello, thank you for the information. Could you please tell me, can a non-EU medical device manufacturer ship the product directly to the customer when they have an EC rep?

[@EasyMedicalDevice]

Purni Sam a Non-EU medical Device manufacturer cannot ship directly to customers as first the products need to arrive to the importer. With the EU MDR 2017/745, the importer should verif that the product is correct before placing a label on it. Only an EU medical Device manufacturer and an EU importer can place a medical device on the EU market.

[@robertmarko2337]

Great stuff indeed, very thorough! Making the sound quality better would be awesome in the future! :) I've got many questions of mine answered. Thank you! Actually I was wondering if I'd pick a medical device to sell from an already existing European retailer. Could I rename the product and if yes, at what cost? Cheers!

[@EasyMedicalDevice]

Hi Robert, thanks for your feedback. This is really helping. If you look at the more recent video, you'll see some progress on the sound and video quality. When I look at my first videos and my last one I am really happy that there is a huge difference. I really hope you'll get value out of them. Don't hesitate also to go on the website to get more information. easymedicaldevice.com Regarding your question, this is called Own Brand Labelling and this technique is not really allowed anymore with the new MDR or this is allowed only if you have all the manufacturers documentation. I also wrote an article on it on my website. Search for it on the blog section. It's called Own Brand labeling or OBL.

[@norah_roadtrip]

Helpful video. Thank you.

[@shreyadevkar880]

Really good video! Understood all the points!

[@EasyMedicalDevice]

Thanks. Really appreciated. It is really an old one but all the information are still valid. I have some more recent videos on Economic Operators where I talk more about Authorized Representatives.

[@absoliutlyorganic]

Am i missing something? I thought European Economic Area is: EU nations+European Free Trade Association (Switzerland, Norway, Iceland and Lichtenstein)

[@EasyMedicalDevice]

Hi, I had some struggle also about that. Here is a map showing the differences. boingboing.net/2011/03/12/venn-diagram-illustr.html

[@tomwalet1372]

Hello Monir ! First of all, thank you for your great video. I have a question, the adress of the EU rep has to be added on the labels of newly MDR certified devices only or also on MDD legacy devices ? Thank you very much !

[@EasyMedicalDevice]

Hi Tom, thanks for your message. If you are a foreign manufacturer, for MDD and MDR the EU rep address should be on the packaging behind the EC REP symbol. There is not exception to that.

[@tomwalet1372]

@@EasyMedicalDevice thank you! Yes we are based in Switzerland, so we will have to add this information everywhere I presume (since the MRA no longer valid ! ) ?

[@janakichandra9046]

How to preparing MDR 2017/745 technical file

[@bredakearney3388]

Thanks for sharing - very informative video and easy to follow

[@stdioconio999]

Any body names available who act as authorised representatives?

[@EasyMedicalDevice]

Hi, easy medical device is acting as Authorized representative in EU, UK and Switzerland. Go to our website to see the contact details.

[@rbronsing]

Good video. Thanks for sharing.

[@EasyMedicalDevice]

Thanks Robert. Appreciated. If you are looking for more information on this, you can check my blog post. It's updated.

[@technicalmanager3136]

Please explain that HOW someone can BECOME the European Representative?

[@EasyMedicalDevice]

Hi, This can be easy. You should just open a company in Europe and then sign a contract with the company that you would represente. But then there are some obligations as mentioned on the video

[@leonardobruschettibattiboc9888]

Hi @@EasyMedicalDevice, congrats on your video and your answers. Is it a stand-alone business to be Authorized Representative, or usually they are at the same time seller or economical actors in the MD field? To make a long story short, could be possible to set a business based on being an Authorized Representative? Thank you very much.

[@frisoo]

Good 👌🏻

[@EasyMedicalDevice]

frisoo style thanks for your message. Motivating