Medical Device Regulatory Guide

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MDD, AIMDD, and IVDD Harmonised Standards Amended 💥

The Commission Implementing Decision (EU) 2021/610 on 14 April 2021 has amended the harmonised standards for the Medical Device Directive, Active Implantable Medical Device Directive, and In Vitro Medical Device Directive.

🔍 MDD

·         Commission Implementing Decision (EU) 2021/610 - https://bit.ly/3axSdES

🔍 AIMDD

·         Commission Implementing Decision (EU) 2021/611 - https://bit.ly/3n9hXfK

🔍 IVDD

·         Commission Implementing Decision (EU) 2021/609 - https://bit.ly/3sF79ag