Episode 3 – Is my Product a Medical Device in Europe?
Medical Device made Easy Podcast
English - December 20, 2018 14:04 - ★★★★★ - 17 ratingsCareers Business Education Courses medical device regulation medtech industry regulatory affairs iso mdr 2017/745 Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
Medical Device made Easy Podcast Episode 3- On this episode I help you to define if your product is a Medical Device in Europe? I know it sounds basic but you´ll see that the new Medical Device Regulation MDR 2017/745 is changing the rules. So listen carefully.
The post Episode 3 – Is my Product a Medical Device in Europe? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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 definitionStep 2: Medical devices without a Medical PurposeStep 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
or
Alexa
Just send me on my Linkedin or Twitter or Facebook or Instagram account
Resources
Episode 2: MDR 2017/745. LinkIs my product a Medical Device? LinkArticle: Medical Device Definition: LinkBorderline manual: LinkFree Mini-Course: EU MDR 2017/745: LinkAlexa Skill “How many days”: Link
Video
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