Classification of medical devices
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Yes, you are right. Separately, those elements do not need a medical device file, but, once they are all put together, technical details must be a part of the Medical device file for the X-ray system. It means that at least the following must be covered:
- technical drawings
- materials from which it is made of
- What risks do the elements in question have on the patient, ie on the accuracy of performing the diagnostic procedure
- any other safety issues
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Nov 29, 2021

