Many medical devices rely on software to ensure efficacy, safety and quality. The MDR has special technical restrictions for software, irrespective of how it is used.
Software in the medical device industry represents a rapidly expanding area in health care. Digital healthcare platforms are constantly evolving and increasingly play a vital role in all areas of a patient health, from diagnosis and treatment to monitoring.
As an integral part of medical devices, software may be used to manufacture or maintain a device, or the software itself can be a medical device. In all cases, the software must meet certain requirements and comply with the regulations. Therefore, it is important to determine which rules apply.
