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....
Class I Software according to MDR – is that still possible? (September 2025)
Are there still Class I software medical devices according to MDR? Are regulatory authorities really withdrawing Class I software products from the market in droves? Which federal state do I need to go to in order to remain on the market with my Class I software? As...
Classification of software medical devices: MDR Guideline
“The use of my app is completely safe. It certainly falls into the lowest risk category.”- MDR probably sees it differently. Anyone who wants to certify their software as a medical device in accordance with the Medical Device Regulation (MDR) must deal...
Data Security & Data Protection Certificates for DiGA
Digital health applications (DiGA) require certificates for data security and data protection. Following repeated problems with the handling of personal data in some DiGAs in the past, manufacturers will have to have their applications checked more closely in future...
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