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Medical Software – The Case for New Regulation

September 23, 2019

Continued scientific and technical developments have pushed the medical devices industry to the point of big change. What now?

We can no longer imagine modern healthcare services without medical devices. They perform a vital role in diagnosis and treatment. Medical devices range from basic equipment, like thermometers and syringes, to more complex surgical instruments, pacemakers, prostheses, catheters, and therapeutic and diagnostic equipment. These more complex, high-risk devices are often responsible for protecting and sustaining human life.


Medical devices have become more complex, and so has the software at the heart of them. Besides controlling and monitoring medical devices, advanced software opens the door to a vast array of new functions and features.


For example, using wireless communication technologies means that medical devices can connect to other devices, including computers and smartphones. With wearables sensors and machine learning it’s possible to collect data, send it to a doctor and automate the delivery of treatment. Artificial intelligence is already helping to improve diagnostic image clarity too. And these are just some examples of how medical software has improved healthcare and medical devices in recent times.


However, this fast-paced evolution has also given rise to new challenges for manufactures, lawmakers and regulators.


Just last year, medical device recalls reached record highs, with software the most common factor for recalls. In fact, software issues have been the main reason for device recalls since 2016.


There seem to be three main reasons for this increase. First, the number of medical devices using advanced software is now higher. Second, this kind of software needs constant updates which can raise post-market issues after the device has been released. Third, as manufacturers create more innovative software, the number of variables in a clinical environment that need to be taken into account grows.


As the spread of high-tech medical devices continues, the challenges with software aren’t expected to reduce, especially now with a new medical regulation on the way.

In 2017, the European Council and Parliament approved the new Medical Device Regulation (MDR). This will come into effect in May 2020, introducing significant changes that are mandatory for companies to comply with. Medical devices can no longer be delivered to the European market without conforming to the strict safety requirements of the European Union’s new regulations.


Previous regulation had failed to consider software’s own role as a medical device. But this new regulation will change this. All devices containing software, including medical apps that were not previously considered medical devices, will be classified as a medical device.


Manufacturers will face new challenges because of this. Minimising failures and recalls caused by software while still encouraging innovation will be a delicate balance to strike. It will require continuous effort from manufacturers who will need to adopt a proactive approach to understanding and implementing the new regulation.


If you would like to know more about the impact of the Medical Devices Regulation coming into effect in 2020, download our free white paper.

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Medical Devices