Software as a medical device
Software as general medical devices
Medical software can be considered a medical device if its primary intended purpose is to diagnose, prevent, monitor, or treat medical conditions in humans. This includes software that provides information for diagnostic or therapeutic decision-making, supports clinical management, or aids in patient monitoring.
Examples of medical software that can be classified as medical devices under the MDR include:
- Diagnostic imaging software for radiological or pathological analysis.
- Software used to control or adjust the function of medical devices, such as infusion pumps or pacemakers.
- Mobile health applications (health apps) that provide medical information or assist in disease management.
Software as in vitro diagnostics (IVDs)
Medical software can be considered an IVD if it is specifically intended for in vitro examination of specimens derived from the human body to provide information for the diagnosis, prevention, or monitoring of diseases.
Examples of medical software that can be classified as IVDs under the IVDR include:
- Laboratory information systems used for specimen processing and test result management.
- Diagnostic software used to analyse samples and detect specific biomarkers or pathogens.
The classification of medical software as a medical device or an IVD under the MDR or IVDR has significant implications for regulatory requirements. Manufacturers must comply with the applicable regulations, including conducting conformity assessments, preparing technical documentation, and affixing the CE marking before placing the software on the market.
