Accessory for a medical device

Device designed to support, supplement, or enhance the performance of a medical device. It is not an independent medical device.

It is either equated to the class of the original device or classified as Class I and entered into the Register of Persons Responsible for the Introduction of Medical Devices, Active Implantable Medical Devices, and In Vitro Diagnostic Medical Devices.

Components supplied to replace existing parts of a finished device, for which conformity assessment with technical regulations has already been conducted, are not considered medical devices. However, if the components significantly alter the characteristics or performance of the finished device, they are recommended to be treated as separate medical devices.