Classification of medical devices
Short definition
Classification of medical devices is the assignment of each device to a risk class (I, IIa, IIb or III), according to the rules in Annex VIII of Regulation (EU) 2017/745.
In plain language
The class depends on the intended purpose and on factors such as the duration of contact with the body, the degree of invasiveness and whether the device is active. Class I is the lowest risk and Class III the highest. The higher the class, the more demanding the conformity assessment procedure and the greater the involvement of a notified body.
In practice, in an RVer session
The RVer base product is classified as Class I.