Relatively aside, even within our own office, was the document MDCG 2021-3 - Questions and Answers on Custom Made Devices, for Czechs the old - fashioned "individuals". I will refer to them in this article by the abbreviation CMD.
And it was a shame, because the changes in the view of CMD are huge. The evolution of technology has significantly changed the CMD field. Previously, the field was the domain of hand-crafted prosthodontists who created CMDs at their own personal risk. Moreover, these were always first-risk class medical devices. However, fundamental changes have taken place. These include the automated digital transmission of patient characteristics from MRI or CT scans, the industrial division of labour, the introduction of 3D printing and, for example, the manufacture of implants. Global IMDRF does not consider these practices to be compatible with CMD and this way of looking at it has also been adopted in the text of the MDR. A distinction should therefore be made between CMD, adaptive medical devices and patient-adapted medical devices. This last category in particular will be a common trap for many manufacturers convinced that they are producing CMDs. In order to meet the definition of a CMD, a manufacturer must meet several conditions simultaneously. The two "problematic" ones are:
Production must be based on specific design characteristics prescribed by an authorized person (usually a physician) that include unique anatomical and physiological features or pathological condition of the patient, or drawings, molds, models. These may not be automated data transmissions in the form of images or CT data. Targeting to the manufacturer's workstation is also not acceptable.
CMDs are not devices that are mass produced using industrial manufacturing processes. In this case, scaling the design based on anatomical references from the patient's imaging, batch manufacturing through a process that can be validated and reproduced, or tailoring the design to the patient's anatomy at the manufacturer's responsibility are also disqualifying.
I know this is something most CMD manufacturers won't want to hear. The regulation of modern technology does somewhat throw the baby out with the bathwater, but alas, a head tucked in the sand won't solve anything. It will take a proactive approach by the regulators to completely clear up any doubts going forward. SÚKL will certainly be helpful in this area so that all manufacturers know where they stand in due course.
Author: Aleš Martinovský
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