Legislation as a driving force for safe and responsible healthcare software

Medical software is increasingly under strict supervision. European legislation imposes higher requirements on safety, transparency, and reliability. This also affects digital healthcare solutions like those from Topicus. As a developer of medical software, we have the responsibility to demonstrate that our solutions not only deliver what they promise but are also demonstrably safe. The MDR (Medical Device Regulation) compels us to structurally guarantee this. And that is absolutely essential: not only because of legislation, but because healthcare professionals and patients rely on us. 

What the MDR means for software vendors

The MDR has been in effect since 2021. This European regulation imposes stricter requirements on medical devices, including software that performs a medical function. This means that solutions that support diagnosis, triage, or treatment decisions must now meet strict requirements. These include technical documentation, risk assessment, user research, and external assessment by a notified body. 

The impact on the healthcare sector

The MDR transition period runs until the end of 2028. After that, uncertified software products will no longer be permitted for use in the medical domain. Healthcare institutions will then be legally obligated to verify that their suppliers comply with the MDR. For suppliers like Topicus, this means that compliance is not optional, but essential to guarantee continuity of care. 

Compliance as an integral part of development

Topicus' Healthcare division established an MDR Taskforce, comprised of experts from various disciplines. This working group developed a Quality Management System (QMS) compliant with ISO 13485 and based on the international standard IEC 62304, which defines lifecycle processes for medical software. 

A key element of the approach is incorporating risk assessment and user research into software development from an early stage. For example, during the redevelopment of a triage functionality, extensive research was conducted to prevent user errors, including through improvements in UX and workflow. 

First results from practice

An initial audit has now been conducted by the notified body BSI, which identified only a few areas for improvement. Topicus' Healthcare division is currently finalizing more than 200 documentation items, including risk registers, validation plans, and test reports, in preparation for full certification under the MDR. 

Innovation within frameworks: possible and necessary

Innovation and compliance aren't mutually exclusive. By combining agile development methods with quality and risk management, it's possible to stay within legal frameworks and innovate rapidly. This requires conscious choices: close collaboration, early assessment of design decisions, and the systematic inclusion of risk assessments. 

In the case of artificial intelligence applications, where software continues to adapt after delivery, it is also assessed at an early stage whether the application falls under the MDR or will soon be subject to the emerging AI legislation. 

Quality is central to tomorrow's healthcare

The MDR is changing the way medical software is developed and accounted for. This requires new working methods, different collaborations, and a culture where quality and safety are central from the very first line of code. Only if digital healthcare solutions are demonstrably safe and effective can they continue to add value to the healthcare of tomorrow.