Guide: Is your software a medical device?
That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Software must also be classified as a regulated medical device under the Medical Device Regulation (MDR) if it is used for specific...
Approving software medical devices without quality management and regulatory requirements?
The Medical Device Regulation (MDR) poses many challenges for manufacturers of software medical devices. In addition to establishing a quality management system (QMS) and preparing technical documentation, manufacturers face regulatory liability risks. For many...
Is your app a DiGA? Definition criteria of digital health applications
So-called DiGA (digital health applications) can be reimbursed by statutory health insurance companies. This became possible for the first time when the Digital Supply Act (DVG) came into force on December 19, 2019. However, not every health app or medical app meets...
13 Tips for DiGA Approval in 2025
Implementing a digital health application (DiGA) involves effort and costs that should ultimately pay off for your company. And indeed, many certified DiGA that make it onto the market show extremely positive prescription and sales figures. Others, however, do not...
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