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What is SaMD – How will it be Regulated?

 

Medical Devices are evolving with the development in technology and advancing healthcare requirements. MedTech companies collect patients’ performance information, which creates a crucial data trend in the MedTech Industry. It is essential to understand what exactly SaMD (Software as a Medical Device) is in such advancing times.

 

IMDRF defines “Software as a Medical Device” (SaMD) as a software used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

Any algorithm, code, or software program used for medical purposes and is not a part of a hardware medical device will be classified as SaMD. A thin line of difference is stated in MDR classification where - Software for general purposes, even when used in a healthcare setting, or software intended for lifestyle and well-being purposes is not a medical device.

 

In such scenarios, the correct classification of your software will give you the right pathway to conformity. MDR Guidance on Classification presents the following decision tree.

Based on this decision tree, the classification process becomes more accessible. The EU MDR effective 26th May 2021 has also upgraded the classification policy. If the software is classified as a Medical Device, then the software is no different from the scalpel, stethoscope, and other medical devices.

 

The new Guidelines will then further categorise the software in Classes, where there are 4 main categories:

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