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

Medical Device made Easy Podcast · Dec 20, 2018

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…