13 Tips for DiGA Approval in 2026
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...
Draft Amendment to the MDR (2025): Implications for Class I Software
In the currently valid version of the Medical Device Regulation (MDR), there is considerable room for interpretation when it comes to classifying software medical devices. In particular, the distinction between risk classes I and IIa is vaguely worded. Manufacturers,...
BSI TR-03161 for DiGA: Data Security Certification
Since January 1, 2025, manufacturers of digital health applications (DiGA) must prove compliance with data security requirements by means of an official certificate. The basis for certification is BSI TR-03161, which was first published in 2020. The BfArM checks...
IVDR Software: Qualification & Classification
Many in vitro diagnostic devices today consist not only of physical test kits, but also of complex software that calculates, interprets, or visualizes analysis results. As a result, more and more software is falling within the scope of the In Vitro Diagnostic...
Sprechen Sie mit unserem Geschäftsführer Malte Bucksch