Is my product a Medical Device in Europe ? (EU MDR 2017/745)

Podcast Webpage: https://podcast.easymedicaldevice.com/3/

On this episode of the Medical Device made Easy Podcast with Monir El Azzouzi, I will give you some tools to define if your product can be considered as a Medical Device in Europe following the new EU Medical Device Regulation MDR 2017/745.

As you may know, there is a lot of varieties of products with new technologies that appear so it can be a challenge for a company to define that.

I will then go through a 3 step process to help you answer this question:

- Step 1: Medical Device, Accessory, Intended use definition
- Step 2: Medical devices without a Medical Purpose
- Step 3: Borderline products

When you´ll go through those 3 steps, you´ll then be able to answer your question.

The Medical Device Regulation is new for everyone, so take your time to learn it before to rush. With this episode, we´ll start with the basics but I think it´s really important.

Enjoy this episode! And don´t forget to subscribe.

Alexa Skill – “How many days”
As mentioned in this episode, I´ve created a basic Alexa Skill that tells you how many days remain until the New medical device regulation.

Download it on your device with the link on the resource section. Then to activate it, you should say:

- Alexa, open How Many Days
or
- Alexa

Just send me on my Linkedin or Twitter or Facebook or Instagram account (See links below)

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Links from the Video

Episode 2: MDR 2017/745: https://podcast.easymedicaldevice.com/002/

Is my product a Medical Device? :https://easymedicaldevice.com/is-my-product-a-medical-device/

Article: Medical Device Definition: https://easymedicaldevice.com/medical-device-definition/

Borderline manual: http://ec.europa.eu/DocsRoom/documents/26785/attachments/1/translations/

Free Mini-Course: EU MDR 2017/745: https://easymedicaldevice.com/mdr
Alexa Skill “How many days”: http://a.co/0RXz5zp

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Social Media to follow

Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

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#medtech #medicaldevice #compliance

Видео Is my product a Medical Device in Europe ? (EU MDR 2017/745) канала Easy Medical Device