Demonstration of Equivalence - Need for comparing biological characteristics for an SamD

akp060

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#1
I would like to know if a comparison of biological characteristics is required for the demonstration of equivalence in the context of Appendix A1 of MEDDEV 2.7/1 revision 4, when the Device under Evaluation is a SaMD (Software as a Medical device) device
 
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planB

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#2
Since MEDDEV 2.7/1 rev. 4 defines biological characteristics on p. 32 as:

Biological: Use the same materials or substances in contact with the same human tissues or body fluids.
demonstration of biological equivalence is not applicable to your case. This is also in line with applicability of the ISO 10993 standard series, also mentioned on p. 32 in this context.

HTH,
 
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