How to handle Software/Firmware to be MDR compliant?
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Yes, you are right that Biocompatibility does not apply to the software. But other documents are applicable with some adjustments.
First what you need is to go to Annex I; - General safety and performance requirements and to see which of those requirements are applicable for you.
Then, I suggest going to the following MDCG guidance that are specific for software as a medical device:
- Is your software a medical device? https://ec.europa.eu/health/system/files/2021-03/md_mdcg_2021_mdsw_en_0.pdf
- MDCG 2020-09 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2020_1_guidance_clinic_eva_md_software_en_0.pdf
- MDCG 2019-16, Rev 01 - Guidance on Cybersecurity for medical devices https://ec.europa.eu/health/system/files/2022-01/md_cybersecurity_en.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
Also, be aware that medical device software must be in compliance with the following standard: IEC 62304:2006 - MEDICAL DEVICE SOFTWARE — SOFTWARE LIFE CYCLE PROCESSES
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Jan 22, 2022