EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device;


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What information should be included in the Performance Characteristics of the device in the IFU. Is it like the Warnings and Precautions?
What exactly is needed to satisfy this requirement?
Much appreciated!


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Perfromance characteristics typically refers to accuracy and specification (environmental, EMC, Etc.).


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I have the same questions...... What would be considered "performance characteristics" for an implant, such as an intraocular lens or a spinal implant? I get confused with the specifications..... Would appreciate any help on this...!
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