The new EU Medical Device Regulation EU MDR 2017/745 with Monir El Azzouzi

[@dhanushpsg5927]

Thank you so much

[@moonswhite1409]

Thank you very much
Very very helpful content :)

[@EasyMedicalDevice]

You‘re welcome.

[@halaaltayar9448]

Thank you

[@mohammedasif7667]

Hi
Question ; Assume i have a company in Arab and I open up one more plant in Europe so in this do we need Notified body, ec rep distributor, importer ??
Like I manufacturers it and want to deliver to Europe

[@EasyMedicalDevice]

Hi Mohammed,
If you have a company in Europe then you don‘t need an EC REP or importer. For the Notifief body it depends of the product class. In or out of EU you will need a Notified Body if your product is higher than class I

[@EasyMedicalDevice]

if you prefer to listen to Medical Device made Easy Podcast on your preferred platform as iTunes, Spotify, Soundcloud... please look at podcast.easymedicaldevice.com