Clinical Evaluation MDR


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Since we do neither know the type of device nor the materials in question, we cannot answer that question. I have seen the claim on both materials being biocompatible, maybe it works. Maybe not. But since it is a class I device, hence low risk, this could be possible.
In my opinion, a good justification goes a long way.
Thank you. It is a speculum (the new material is basically the only innovation)


Starting to get Involved
According to MDR Annex XIV Part A
Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables.
It requires the same material, and even if I try to claim equivalency using ISO 10993, the material supplier states that our material is not equivalent to the clinical equivalent device.

I'd like to share an anecdote on this point. When considering device equivalence, we reached similar roadblocks as described by doracre (Able to demonstrate clinical & technical equivalence, but not biological). This was due to the interpretation that same material does, in fact, mean the same material (ie - cannot be supported by biocompatibility). MDCG 2020-5 seems to support that conclusion.

However, during the TD assessment of a class IIa device our reviewer noted that biological equivalence may be considered 'too strict' given the somewhat simple nature of the device in question. We are still awaiting final acceptance of the TD assessment, but given those comments we did end up claiming equivalence and I imagine that will be accepted. As raisin picker said, perhaps a solid justification can work in certain cases.
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