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
    Don't forget to follow Medical Device HQ on LinkedIn:
    / medicaldevicehq
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ความคิดเห็น • 3

  • @aniawo5119
    @aniawo5119 ปีที่แล้ว +2

    Smashing presentation, thank you!

  • @AnaPaula-ig5uf
    @AnaPaula-ig5uf 11 หลายเดือนก่อน

    Very clear explanation. Thank you

  • @f.s.9833
    @f.s.9833 5 หลายเดือนก่อน

    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?