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MDCG Manual on Borderline and Classification (Version 4)

September 23rd, 2025 - Eoin Philip Kelly

MDCG Manual on Borderline and Classification (Version 4)

Borderline products remain one of the trickiest challenges under the EU Medical Device Regulation (EU) MDR 2017/745 and the In Vitro Diagnostic Regulation (EU) IVDR 2017/746.

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