Edit Reference: Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9)

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Comment:	EU implementing decision on harmonised standards for quality management and risk management for devices
Content:	COMMISSION IMPLEMENTING DECISION (EU) 2022/729 of 11 May 2022 – amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices (9) The references of harmonised standard EN ISO 13485:2016 on quality management systems and its amendment EN ISO 13485:2016/A11:2021 are published by Implementing Decision (EU) 2021/1195.

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