Medical Device Regulation 2017/745

Medical devices, accessories of medical devices and medical software must comply with all the relevant design, safety and performance requirements, in accordance with the Medical Device Regulation 2017/745. In order to define a product as a medical device, it must first be classified based on a risk classification. Depending on the main purpose and the risk of the medical device, there are four main risk classes: I, IIa, IIb en III. A medical device refers to any instrument, device or device, software, implant, reagent, material or other item intended by the manufacturer to be used in humans for diagnosis, prevention, monitoring, prediction, prognosis, treatment or relief of illness, injuries or disabilities.

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