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

A

akp060

Involved In Discussions
#1
#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
 
planB

planB

Super Moderator
#2
#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.
Click to expand...
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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