WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 4.2-classify: Manufacturers classify each device and IVD by the harmonized risk-based rules, applying the higher class where two could apply, and accept that the NRA may review or overturn the class

What does 4.2-classify require?

The manufacturer carries the first duty to assign its device to a risk class under the rules the NRA adopts, normally the four harmonized classes A to D (low to high). For devices other than IVDs the class turns on features such as invasiveness and duration of contact, active function, delivery of energy, medicines or radiation, incorporation of medicinal substances or human or animal tissue, life support and use by lay persons; for IVDs it turns on intended use, intended user, how decisive the result is and the effect of a true or false result on the patient and on public health (a software product that processes IVD output takes the class of its own diagnostic purpose). Where more than one class might fit, the higher one applies; the manufacturer should decide independently on its own design and claims rather than relying on example lists. The NRA may question the classification during review or at any time, may reclassify devices as evidence develops, and may offer a voluntary classification consultation.