The Federal Institute for Drugs and Medical Devices (BfArM) has published new answers to frequently asked questions (FAQs) regarding the changes in the Digital Act (DigiG), which came into force on March 26, 2024. Many questions deal with the expansion of digital health applications (DiGA) to include risk class IIb medical devices. This extension is intended to safeguard more complex treatment and care processes and ensure that more innovative technologies reach patients safely. A disclaimer at the beginning of the FAQs informs the reader that the answers are not binding, but if your product falls within the scope of this innovation with your Class IIb digital medical devices, it is still worth taking a look. The same applies to everyone else, as basic questions about DiGA and telemonitoring or DiGA with a diagnostic component are also addressed.
