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,...
All insights: Development and approval of software medical devices in 2026
The development of software medical devices is complex, and unfortunately, high-quality information on the subject is limited on the internet. We have been developing software medical devices for customers on a contract basis for over 10 years. During this time, we...
DiPA Guide: Digital Applications for Care
On December 19, 2019, the Digital Care Act (DVG) made it possible for doctors to prescribe digital health applications (DiGA) to patients in a standardized way for the first time. With the Digital Care and Nursing Modernization Act (DVPMG), a counterpart to this was...
DiGA: Guidelines for demonstrating positive supply effects
What is the point of a DiGA if it does not improve patients’ lives? There is none! This is why DiGAs are only justified when their positive supply effect has been proven. Only then do you have a chance of being permanently included in the BfArM register....
Certification of digital courses according to ZPP – Central Prevention Testing Center
Those who develop digital offerings for health promotion or prevention often face the question: How can these be financed through health insurance companies? Many software manufacturers are familiar with the reimbursement options available through DiGA. Much less well...
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