Hazardous Substances under the MDR
The current Medical Device Directive (MDD) has requirements contained within it (Annex I, #7.5) for medical devices containing phthalates. Many phthalates are “plasticizers”, or materials added to plastics to increase their flexibility, transparency, durability, and longevity. They are used primarily to soften polyvinyl chloride (PVC) and diethylhexyl phthalate (DEHP) is a common example. The requirements in the MDD include labeling the device as containing phthalates and justification for their use if the intended use includes use in children and pregnant or nursing women.