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

This topic contains 1 reply, has 2 voices, and was last updated by  Dylan Choi 1 day, 9 hours ago.

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  • #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!

    #16316 Score: 0
    Dylan Choi

    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.

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