Hi Everyone, Im hoping to solicit clarification on the EUMDR requirements for using a cart with a patient monitor. The cart simply holds the monitor and allows the caregiver to become mobile with the parent device. We are currently looking to have a cart supplier provide us with evidence of compliance to the Machine directive and a CE marking.
Question: Is compliance to the Machinery Directive, CE Marking (from the supplier) and Validation of the cart with the parent device (from the device manufacturer) acceptable to satisfy the EUMDR requirements?
Our organization is considering treating this as a Class 1 and holding the DHF for the cart and essentially owning the cart. Taking ownership of the cart would induce a very large amount of internal compliance work. My gut tells me this is too much and its acceptable that the ownership of the cart reside with the cart manufacturer and not with owner of the parent device.
Help is appreciated
Question: Is compliance to the Machinery Directive, CE Marking (from the supplier) and Validation of the cart with the parent device (from the device manufacturer) acceptable to satisfy the EUMDR requirements?
Our organization is considering treating this as a Class 1 and holding the DHF for the cart and essentially owning the cart. Taking ownership of the cart would induce a very large amount of internal compliance work. My gut tells me this is too much and its acceptable that the ownership of the cart reside with the cart manufacturer and not with owner of the parent device.
Help is appreciated