Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Medical Devide Software

Observations

Classification

Software

Software classifies on its own

STANDALONE

(medial purpose)

Hardware

Software

The software and hardware are sold together as it is not separable from the hardware.

The software is part of the system that is classified as a whole

as a component of the

COMPONENT

Be aware to avoid off label use of the IVD!

The Organisation for Professionals in Regulatory Affairs

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Medical Device Software

Observations (MDCG 2023-4)

Classification

Hardware

Software

The hardware or hardware component is placed on the market as an accessory to the software (or vice versa)

Software and Hardware classify on its own

has as/ is accessory

ACCESSORY

Hardware

Software

The hardware or hardware component is placed on the market as a medical device either as part of a system, as a combination with another MD/IVD or as integral part of a MD/IVD.

Same class as hardware device

drives / influences

DRIVE

Be aware to avoid off label use of the IVD!

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The Organisation for Professionals in Regulatory Affairs

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