Biocompatibility Exemption Rationale

[Abi]

Hi,
I have a Class IIa (Calcium Gluconate Gel) product with over 30-years of use as a 1st aid product in treating (acid) HCL burns. Under MDD, the company claimed exemption from biocompatibility tests (namely - Cytotoxicity, Irritation & Sensitization tests). All Technical Files and ISO Audits were passed with the justification that it's okay since the product does not contain any known leachables. However, this feels inadequate to me as I'm preparing for the MDR Transition audit and have successfully completed the Cytotoxicity test.
My questions are:
1. Are the other two tests mandatory to successfully transition to MDR?
2. What rationale could you suggest for not having the two other tests?
There has never been any report of such side effects with the use of the product. A new Clinical Evaluation Review was recently completed and the PMS activities have no adverse reaction recorded too. Thanks for your support. Regards, Abi.

 

[planB]

In case you have documented objective evidence that your device does indeed not release any (toxic) leachables, your current justification is valid: the biological effects cytotoxicity, irritation or sensitization are all induced by chemicals extracted/leaching from your device. If no leachable chemicals with potential for cytotoxicity, irritation or sensitization are demonstrated to be present through your material-characterisation activities, no further biological testing for these endpoints is warranted. (you are not "exempted" from evaluating these endpoints, though.)

The cytotoxicity test you have already performed, and the PMS data (to some extent) would further substantiate this conclusion.

HTH,

 

[Abi]

Thanks for your swift response. I appreciate it.