Short course on the Medical Device Regulation (EU) 2017/745

This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745" which is available at:

Chapters:
00.00 Introduction
00.11 About the instructor
00.57 The goals of the short course
02.08 The main aspects
07.30 Manufacturer and the Notified bodies
09.43 Conformity assessment and the intended purpose
10.51 Clinical evaluation and clinical investigation
11.18 CE-marking
11.49 The MDR
14.52 Additional resources

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[larahamilton]

🤯 I’m new to this world. However, I sense that this is a great summary of what I need to know!

[Kumaran_K]

This is really amazing. You almost covered all the new changes to EU MDR and can be a great starting point for freshers to understand what is MDR and why it should be and also the part of compliance is explained pretty well. Thanks for the great course amd I know with this many people will get benefited

[lourdesrosales]

thanks!, this is what I definitely needed for start...

[mokar]

My question is : For medical device class Ir: do they need to have CE marking with notified body code? Or only CE with no code?

[joyceeseconors]

Perez Mark Gonzalez Susan Thomas Richard

[sandrabieliauskaite]

Very interesting short course! Do you mind to share a reliable link where I could download up to date MDR 2017/745? Thank you!

[fritzschnitzmueller]

Great short presentation! Thanks for sharing this

[beyzag]

Thank you so much for useful explanation and nice tips!

[profskett]

Thanks for your many interesting and well-presented videos on medical device-related topics! Just wondering, do you plan to make any videos aimed at the UK audience, explaining the difference between applicable medical device regulations in UK vs. EU contexts?