Demonstration of Equivalence for Medical Devices Manufacture

Demonstration of Equivalence shall be performed as per the requirement of Part A, section 3 of Annex XIV of EU-MDR. The MDR (Annex XIV, Part A) establishes that, in order to demonstrate equivalence in relation to other devices, three characteristics must be considered when demonstrating equivalence: technical, biological, and clinical. These characteristics shall be investigated and differences between devices should be disclosed.

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