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Per- and Polyfluoroalkyl Substances (PFAS), commonly known as "forever chemicals", feature extremely stable carbon-fluorine bonds, high bioaccumulation potential and suspected endocrine disrupting properties, leading to stringent regulatory restrictions worldwide. According to OECD statistics, the PFAS family comprises over 10,000 substances. Fluoropolymers including Polytetrafluoroethylene (PTFE), FEP, PFA, PVDF and PCTFE are widely applied in cardiovascular catheters, implant coatings, pacemaker wire insulation, as well as sterile high-barrier packaging for medical devices.

According to the EU MDR Regulation, Appendix I General Safety and Performance Requirements (GSPR) Article 10.4 regarding CMR/EDCs substances: The design and manufacture of medical devices should minimize the risk caused by substances or particles (including swarf, degradation products, and processing residues, etc.) that may be generated by the device. These substances mainly refer to CMR and EDCs substances.