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Episode 3 – Is my Product a Medical Device in Europe?


On this episode of the Medical Device made Easy Podcast, 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 on 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


  • Alexa

Just send me on my Linkedin or Twitter or Facebook or Instagram account


  • Episode 2: MDR 2017/745. Link
  • Is my product a Medical Device? Link
  • Article: Medical Device Definition: Link
  • Borderline manual: Link
  • Free Mini-Course: EU MDR 2017/745: Link
  • Alexa Skill “How many days”: Link


Podcast Episode 3 – Is my product a Medical Device in Europe?

Medical Device made Easy Podcast – Episode 3 – Is my Product a Medical Device in Europe?

The post Episode 3 – Is my Product a Medical Device in Europe? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device made Easy Podcast
A podcast by easymedicaldevice
Helping you placing compliant medical device on the market.

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