Directive Decoder

Europe has witnessed some requests around Canadian medical obligations.

The Canadian Government has required manufacturers and importers to provide information on the presence of DEHP and BPA since 2008.

The information is required for all types of medical devices including electrical and non-electrical equipment. Information on DEHP is required if it is used in the product at a concentration of greater than 0.1% of the equipment (not homogeneous material as with the RoHS Directive). Information on BPA is required for any amount so is needed even if traces are present. However, this is only required if the equipment comes into physical contact with patients or fluids such as for blood transfusions and drips.