Accessories of Medical Devices
As per the MDR the definition of the accessory of a medical device is the article which is intended to be used together with one or several medical devices to specifically enable the medical device to perform a function. Examples of the accessories are Foot switch for the electrosurgical unit, remote control for the electric bed. According to the US FDA regulation, the accessory is a finished device that is intended to support, supplement and/or augment the performance of one or more parent devices.
The details of the accessories have to be included in the medical device Technical file for the CE marking. If the accessories are provided along with the medical device and also included in the packing, then the classification and other details of the accessories to be included in the Technical file.
If the accessories are included in the packing with CE mark, does the manufacturer of it to be the same manufacturer of medical device? Is the software used for the calibration of the medical device is an accessory? Why?
What is the difference between an accessory and a spare part?