Medical Device ‘Hazardous Chemical’ Concentration Limits Set by New Regulation

A new concentration limit for hazard chemicals contained within medical devices has been set at 0.1%. The new regulation has been agreed by Member States and MEPs within the EU.

Any medical device containing reprotoxic, carcinogenic and/or mutagenic substances above the threshold of 0.1% will have to be labelled by the manufacturer. Usage instructions for those more susceptible to these chemicals will also be required by the new regulation.

Instances where alternatives are not suitable due to functionality or performance, or where a benefit-risk ratio favours the original substance, can still lead to the permittance of the hazardous chemical above the 0.1% threshold.