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 . . .
Oh! It looks like you do not have access to this page.
Find the membership plan that suits you, and within a few minutes you are good to go.
Are you a member already? Log in here.