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
- Alexa, open How Many Days
- 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