Accessories of Medical Devices

Accessories of Medical Devices 1

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 enable the medical device to perform a function explicitly.

Examples of the accessories are Footswitch 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 augment the performance of one or more parent devices.

The details of the accessories have to be included in the medical deviceĀ Technical fileĀ for theĀ CE marking.Ā 

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 a 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?