Home Discussions Ask a Question Medical Devices Questions FDA's medical device requirements vs. EU's new MDR?

This topic contains 2 replies, has 3 voices, and was last updated by  Stefan Burnom 2 months ago.

  • Creator
  • #16129 Score: 0

    Cynthia Ramroop

    Hi there,

    I was hoping to get some insight on the biggest differences between the FDA’s medical device requirements and the EU’s new MDR? Any responses would be appreciated!

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  • #16316 Score: 1
    Dylan Choi
    1 vote

    From my experience in the US, you can use a reference device in the approval process however, since this is often a competitor’s device, most manufacturers can only find information on the device from the company’s website. Under the MDR, device applications which refer to a reference device will need to cite specific technical design and performance specifications. This limitation could prevent smaller device manufacturers from getting their product approved in Europe.

    #17018 Score: 0
    Stefan Burnom

    Those are really good points Dylan.

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