ISO 13485 & EU MDR / EU IVDR 2017/746
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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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.
Thank you very much!
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