It is important to note that devices manufactured by healthcare establishments that are only used on their own patients are exempt from the requirements of the medical devices regulations. While this is unlikely to be true of information and communications technology (ICT) equipment per se, it is true of, for example, patient immobilization devices for radiotherapy and surgical implants, which will most likely have been designed using ICT. Custom-made devices (i.e., products manufactured specifically in accordance with a written prescription of a duly qualified medical practitioner or a professional user and intended for the sole use of a particular patient) are not required to follow the normal conformity assessment procedures. However, the manufacturers (and this includes small hospital departments and workshops) do need to register with MHRA. In both cases, while the end product is not subject to the regulations, the software producing them may be, as that is not single-use.
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