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EU IVDR 2017/746

ISO 13485 & EU MDR
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Guest user Created:   Feb 08, 2021 Last commented:   Feb 09, 2021

EU IVDR 2017/746

ISO 13485 & EU MDR

I understood from the webinar that implementing ISO 13485 is a direct way to comply with most requirements in EU MDR 2017/745.

Can the same be stated for EU IVDR 2017/746? Ie that it is beneficial to implement ISO 13485 to comply with IVDR?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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Kristina Zvonar Brkić Feb 09, 2021

Yes, it is absolutely the same with IVDR, that implementing ISO 13485 is a direct way to comply with most requirements in EU IVDR 2017/746

For more details, please see IVDR 2017/746 Article 5 - Placing on the market and putting into service.

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Nicoline Kalsbeek Feb 09, 2021

Thank you very much!

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Feb 08, 2021

Feb 09, 2021

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