custom made medical device definition
custom made medical device means a medical device made specifically in accordance with a written prescription of a registered medical practitioner, specialised in the relevant area, under his responsibility for the sole use of a particular patient, but does not include a mass production of such device;
custom made medical device means a medical device that —
custom made medical device means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. For the purposes of this definition, a duly qualified medical practitioner is defined as a person who is duly qualified by the relevant laws and regulations of the member state where the custom-made medical device is fabricated, and by virtue of his professional qualifications, is authorised to carry out such investigation. For purposes of clarity, , mass produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made medical devices.
More Definitions of custom made medical device
custom made medical device means any device specifically made in accordance with a duly qualified medical doctor 's or dental medicine doctor 's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.
custom made medical device means a medical device, other than a mass produced medical device , that is.—