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Accessories and standalone SaMD

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Maximibus Created:   Jan 17, 2022 Last commented:   Jan 21, 2022

Accessories and standalone SaMD

Could you please provide advise on the following scenario: We are currently working with a medical device class III and in order to fulfil the medical device`s intended purpose, a SaMD is developed and defined as an accessory. There is a strong architecture segregation according to a risk based approach and 62304 that ensure the SaMD to be class II based on the FDA: ...an accessory has the same class as the “parent device”, unless there are different risks for the accessory and the parent device. The accessories are then independently classified according to these risks... Is it possible to assume a similar approach will comply with the MDR regulation?   Based on this assumption: Is it possible to reuse the same accessory with other Medical Devices with different classifications, most of them class II and have its own DHF? Is it possible to develop the accessory as a standalone SaMD as an interoperable software as medical device, with interface description, interoperable specification/residual risks etc..and with its own DHF? Is this scenarion feasible in the current MDR regulation? Thank you

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Kristina Zvonar Brkić Jan 21, 2022

This is a rather specific situation and I would like to propose the call. But before that, I advise you to go through these guidelines published by EU Commission:  

Is your software a medical device - https://ec.europa.eu/health/system/files/2021-03/md_mdcg_2021_mdsw_en_0.pdf MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR  - https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdf

I believe that you will find your answers here. If not, let me know and we will arrange a meeting. 

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Jan 17, 2022

Jan 21, 2022