Is software a medical device 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). 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).

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Category: Medical Device

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).

(Visited 1 times, 1 visits today)

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