The 5 most relevant changes the Medical Device Regulation MDR introduces, that you must know

Well described. Could you please tell me about MDCG and how they are going to help manufacturer?

Thanks, good overview

Nice overview.
What I see missing is the mapping between the Software as Medical Device and the Rule 11 of the MDR.
If you have a product both in the European and U.S. market is now difficutl to understand e..g if you softare is class IIb or Class III.
The unclear point is about the "death" or "irreversible" health state of the patient. This is not covered by SaMD...
Do you have suggestions about?

can I get a hard copy for this presentation

Are these 3 items considered as medical devices?:
Milling machines for dentists?
3D printers?
3D dental scaners ( not Intra Oral)
Resins for dentists?
Otherwise how are they classified?
Thank you so much

thanks

Thanks for a great video! Could you further explain why it will be a disaster for startups & a killer of innovation ?

You are great . Thanks for this videos ... I am an Arab engineer learning English

could you tell me 42/EEC means?

Could you please tell me, in
MDR 2017/745, what does 745 indicates?

what do you think where to next for the medical device industry?

Nice video, My dad has been using Blucon Nightrider CGM and FreeStyle Libre for blood glucose monitoring. He gets glucose updates on his phone and watch too in every 5 minutes without fingerprick. The app gives alarm notification when blood glucose goes up and down. Also, I monitor his blood glucose from any place through Ambrosia Followblucon app. It's a great cgm.

Great explanation!! Thank you

Great. You are great. Thanks for this video

Way of presentation Excellent Sir Pls share same for IVDR 746

Thanks sir
very useful informations.