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IFU compliant
Medical device

Is your IFU compliant with MDR?

The European regulatory landscape has significantly changed over the past 10 years, particularly concerning requirements for Clinical Evaluation (CEP/CER).  This

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MDCG 2019-8 v2 - MDCG 2021-11 - On medical devices
Medical device

MDCG 2019-8 v2

MDCG Guidance documents summary series:   Introduction Under MDD and AIMDD already it was required to provide patients with an

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