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Class I Devices: Non-invasive, everyday devices or equipment. Class I devices are generally low risk and can include bandages, compression hosiery, or walking aids. Such devices require only for the manufacturer to complete a Technical File. Class Is Devices: Class Is devices are similarly non-invasive devices, however this sub-group extends to ...
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Class I devices are the least likely to cause major bodily harm or death in the event of failure, and are subjected to less stringent regulations than are devices categorized as Class II or Class III. [11] In the regulation process, 2021 statistics showed: 47% of devices were class I, [3] 43% were class II [3] and 10% were class III. [3]
A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).
Medical device cannot be classified as a class I device because the controls authorized are insufficient to provide reasonable assurance of the safety and effectiveness of the device. Medical device has sufficient information to establish a performance standard and it is necessary to establish a performance standard for the device.
Many different medical classifications exist, though they occur into two main groupings: Statistical classifications and Nomenclatures. A statistical classification brings together similar clinical concepts and groups them into categories. The number of categories is limited so that the classification does not become too big.
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” [1] whose goal was the standardization of medical device regulation across the world.
There are seven classification rules that are given in Annex VIII. MDCG guidance 2020-16 provides clarification of the classification rules and gives classification examples. [ 1 ] Only devices in the lowest risk class, class A, are excluded from the requirement of notified body oversight.