How to CE mark an Accessory for a Medical Device?

แชร์
ฝัง
  • เผยแพร่เมื่อ 19 มิ.ย. 2024
  • Within EU MDR 2017/745 there is a definition for Accessory for a Medical Device. But how can we CE mark these products?
    For that, we propose you look at this LinkedIn Live with Erik Vollebregt who is a lawyer at Axon Lawyers, and Martin Witte who is working for the Notified Body TÜV SÜD.
    We have collected some questions from the audience and we will answer them. I hope that with this you can understand clearly how to manage your accessories to a Medical Device.
    -------------------------------------------------------------------------------------------
    ► Social Media to follow
    ■ Monir El Azzouzi Linkedin: / melazzouzi
    ■ Twitter: / elazzouzim
    ■ Pinterest: / easymedicaldevice
    ■ Instagram: / easymedicaldevice
    ------------------------------------------------------------------------------------------
    #easymedicaldevice #medicaldevice #regulatorycompliance

ความคิดเห็น • 7

  • @fabiogiudice4173
    @fabiogiudice4173 4 หลายเดือนก่อน +1

    Thanks!

  • @bryanlister8846
    @bryanlister8846 ปีที่แล้ว +2

    Monir - thank you for this, it is a interesting topic that raises many questions. Good to see it being covered.

  • @UKBold
    @UKBold 10 หลายเดือนก่อน

    Great video! One piece that wasn’t covered is how to apply to classification rules to accessories when their intended use is to enable a medical devices intended use?

  • @muhammadfarooqattari7415
    @muhammadfarooqattari7415 ปีที่แล้ว +1

    Thanks , helped a lot

  • @TheDanymaus
    @TheDanymaus 3 หลายเดือนก่อน

    Sorry but I could not derive a clear answer from the question: "Do accessories need to be labeled with MD symbol?" According to ISO 15223-1 it is only to be used for "medical devices" but in multiple forums it is stated that accessories are considered "devices" and therefore should be labeled with the MD symbol. Could you please state your position on that.