PARIS — Software is a significant new area of regulation in the approved European directives for medical devices. The commission defines software as a medical device, subject to regulation and requiring documentation of the development process, “when it is specifically intended by the manufacturer to be used for diagnostic or therapeutic purposes.”

Software used for general purposes within a healthcare setting is not considered a medical device under the directive.

Considering the pervasiveness of computers in the medical environment, Eucomed said it was concerned about the scope of the new directives and offered guidance, using the keyword “stand-alone,” to distinguish regulated and non-regulated software uses.

Stand-alone software used in the context of a medical treatment for data collection or transfer without “participating” in that treatment should not be considered as a medical device. As an example, the software for a reprogrammable pacemaker is an integral part of the medical device, said Eucomed, and therefore a medical device. Similarly, special software used to monitor, and to analyze the patient’s vascular activity, also should be considered a medical device.

Software included as part of computerized patient management system that collects the data from the pacemaker for storage and statistical analysis clearly is not a medical device, the association said.

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