There is no simple answer to this question as it depends on various factors, such as the intended use of the software, whether it is stand-alone or part of a system, etc. In general, however, software used for medical purposes (e.g., to diagnose or treat a patient) is considered a medical device and subject to the Medical Device Regulation (MDR). Generally speaking, the software is not considered a medical device, but there are some exceptions, for example, software that is used to generate results from medical images is considered a medical device under the European Union’s Medical Devices Directive (MDR).
There is no simple answer to this question as it depends on various factors, such as the intended use of the software, whether it is stand-alone or part of a system, etc. In general, however, software used for medical purposes (e.g., to diagnose or treat a patient) is considered a medical device and subject to the Medical Device Regulation (MDR) and Generally speaking, the software is not considered a medical device, but there are some exceptions, for example, software that is used to generate results from medical images is considered a medical device under the European Union’s Medical Devices Directive (MDR).
