What is a medical device according to the MDR
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- เผยแพร่เมื่อ 22 พ.ค. 2024
- This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745" which is available at:
medicaldevicehq.com/medical-d...
Read more about what medical devices are according to the MDR here:
medicaldevicehq.com/articles/...
Chapters:
00:00 Introduction
00:30 About the instructor
01:19 What is a medical device?
03:05 Intended purpose
04:49 Clinical evaluation
06:04 Deciding on what is a medical device
09:02 Other medical device products
10:08 Products regulated as medical devices
11:09 MDR
11:59 Legal manufacturer
13:24 Additional resources
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Smashing presentation, thank you!
Very clear explanation. Thank you
Prescription glasses are classified as class I. However, what about glasses that are not prescription glasses and are used solely for cosmetic purposes? I would say they aren’t classified as a medical device. And something I am wondering is what about smart glasses. They would contain software and could show your pulse, etc if they were connected to your Apple Watch. How would you classify those? Are they still class I or are they automatically class IIa? Would you classify them the same whether these are prescription smart glasses or glasses without prescription that are smart glasses too?