Medical Device Components

The Medical Device Components is an integral part of the device that helps to perform its intended purpose. Sometimes the software may be the functional component of a medical device. For eg. In a digital ECG machine, there is software component which convert the analog ECG signals and displays it on the LCD screen. Hence the components are key functional element of the medical device.

The details of the key functional components for medical device and its raw materials has to part of the Technical file for the CE marking. The Medical Device Components may be in packed as assembled or as individual parts for the customer to assemble. Hence the instruction for use should contain the detailed information for the assembling of the device with the help of diagram.

If a medical device has multiple components which individually also form a medical device, how can we classify the medical device according to MDR? What is the difference between an accessory and a component? Does the variants of a medical device related to components of it?