Module 12 Presentations

29/01/2024

MDD rule for Software

• Stand alone Software is considered to be an active Medical Device • Software which drives a device or influence the use of a device, falls automaticallyin the sameclass • Rule 12 – All other active devices are in Class I

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MDR rule for Software

• Software, which drives a device or influences the use of a device, shall fall within the same class as the device . • If the software is independentof any other device, it shall be classified in its own right .

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