Accessory

ISO 20417 notes that some regulators treat an accessory as a medical device and some define it differently. Under the EU MDR, accessories for a medical device are regulated as devices in their own right.

item, intended specifically by its manufacturer, to be used together with one or more medical devices to specifically enable or assist those medical devices to be used in accordance with their intended use Note 1 to entry: An accessory is typically a consumable or separate item for use with one or more medical devices. Note 2 to entry: Some authorities having jurisdiction consider an accessory to be a medical device. Note 3 to entry: Some authorities having jurisdiction have a different definition of accessory.

ISO 20417:2021, clause 3.1