What is new under the EU MDR for software manufacturers?
Erwin WaasSenior RA Manager
E-Health solutions, like web-based applications or those available in app-stores, have in recent years become more focused on contributing to health improvements. With more possibilities for these smart applications on phones and tablets to communicate between physician and patient there is clearly a potential for added value. Physicians, when using these tools, can remotely monitor patient wellbeing, diagnose or even make treatment decisions based on clinical data. Also, the combination of functionalities like the ability to obtain personal health data via measurement, retrieval from archive and calculation through algorithms gives software devices significant clinical importance.
This all sounds great and is great because these tools potentially increase healthcare efficiency by reducing cost and effort for patients, physicians and health institutions. Also, patient involvement in managing their health is seen as a step forward. One essential requirement, however, is that these products should also be effective and safe and be applied for what they are made for. One way of securing this is compliance to the current EU legislation for medical device software and compliance to international standards.