SOFTWARE: Qualification and classification

On the 11th of October 2019, the MDCG issued a Guidance on the qualification and classification of software under the MDR and IVDR.

The MDCG first defines “software” as a set of instructions that processes input data and creates output data. Non-exhaustive list of both types of data is provided in the Guidance.

The MDCG differentiates software from a Medical device software (MDSW), which is software that is intended to be used, alone or in combination, for a purpose as specified in . . .

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