Natural Rubber / Latex Product CE Marking - Requirements

mpfizer

Involved In Discussions
Natural rubber / latex products being cytotoxic can be they be CE marked and if yes how does one mitigate the risk.

Thanks

Regards

michelle
 

Ronen E

Problem Solver
Moderator
Natural rubber / latex products being cytotoxic can be they be CE marked and if yes how does one mitigate the risk.

Thanks

Regards

michelle

There are no current EU limitations posed specifically on devices containing latex / natural rubber. The risk is mitigated through biological evaluation (eg ISO 10993) and general risk management - refer to the MDD ERs.

The upcoming EU MDR will require manufacturers to notify the (future) UDI database whether a device contains latex or not.

According to the FDA, "Contact with devices containing natural rubber has been associated with anaphylaxis in individuals allergic to natural rubber latex proteins" (https://www.fda.gov/downloads/medic...onandguidance/guidancedocuments/ucm342872.pdf). Did you encounter cytotoxicity issues during actual testing?
 
Last edited:

mpfizer

Involved In Discussions
YES, we did encounter cytotoxicity issues during biocompatibility testing.

we have been informed that natural rubber latex is cytotoxic in nature
 
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