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

Welcome to this episode of Medical Device made Easy Podcast with Monir El Azzouzi. Today you´ll learn all about the new EU Medical Device Regulation. From its origin to how to implement it.
If you want to participate in a Free Mini-Course on the new EU MDR 2017/745, don´t hesitate to learn more here.
Within this episode I will explain to you:
- The origin of the new Medical Device Regulation
- The transition period
- A summary of the changes
- How to implement this change
--------------------------------------- Alexa Skill ---------------------------------------
I just created an Alexa Skill that you can download with the link below, on the resource section of this episode.
This skill is called “How Many Days”. You can download it on your Alexa Account by clicking on the link.
To activate it you need to say:
- "Alexa Open How Many Days"
- "Alexa, ask How Many Days until the new Medical Device Regulation"
I know this is more a gadget but I will create more sophisticated ones. Just give me some time.
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- Link: podcast.easyme...
---------------------------------------- Resource -----------------------------------------
- Subscribe to the Free Mini-Course MDR 2017/745: easymedicaldev...
- MDR 2017/745 Transition Timeline blog post: easymedicaldev...
- Alexa Skill: How Many Days until the new Medical Device Regulation: a.co/0RXz5zp
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- Instagram: / easymedicaldevice
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#medtech #medicaldevice #compliance

[@dhanushpsg5927]

Thank you so much

[@halaaltayar9448]

Thank you

[@moonswhite1409]

Thank you very much
Very very helpful content :)

[@EasyMedicalDevice]

You‘re welcome.

[@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]

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