Help is at hand: New guidelines for medical device software

The regulatory interaction between medical device software, hardware and hardware components has been sought clarified in the new guidelines.

The Medical Device Coordination Group, which is a working group established in accordance with the Medical Device Regulation, has recently adopted new guidelines for medical device software ("MDSW"). 

It is worth noting that software is an essential part of an increasing number of medical devices, and that around 25% of all medical devices either utilise MDSW or are MDSW in themselves.

MDSW can be used in medical devices and in conjunction with hardware, such as sensors or cameras (hardware components), where the software processes data to serve a medical purpose. For instance, MDSW could be downloaded as an app on a smartwatch, enabling disease prevention and monitoring through the software continuously analysing data, such as heart rate and temperature, received from sensors built into the smartwatch (hardware).

This interaction between MDSW, hardware or hardware components raises the question of how hardware or hardware components should be qualified and assessed when used with MDSW. Especially as individual hardware devices do not necessarily serve a medical purpose before they are used in combination with MDSW.

The new guidelines aim to clarify this issue by providing a number of typical examples of the use of MDSW, hardware and hardware components which are then considered in relation to the Medical Device Regulation. 

Read the guidelines

Want to know more?

If you would like to know more about medical devices and MDSW, please contact the Plesner Life Science team

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