Removing Regulatory Barriers for Medical Device OEMs

This case study outlines the challenges faced by medical device Original Equipment Manufacturers (OEMs) in obtaining product approvals due to evolving global regulatory requirements, particularly under the European Medical Device Regulation (EU MDR). The regulation imposes stringent risk assessment requirements for devices that utilize animal-derived materials, complicating the approval process and potentially delaying the speed to market. In response, Lubrizol has developed medical-grade polymers that incorporate non-animal derived lubricant additives, providing a solution that maintains performance while alleviating regulatory burdens. By offering these innovative materials, Lubrizol enables OEMs to navigate the complexities of regulatory approvals more efficiently. The case study details how this proactive approach not only simplifies the approval process with the EU MDR but also enhances the likelihood of obtaining approvals from other regulatory agencies. Ultimately, this initiative supports OEMs in bringing their products to market more quickly, thereby benefiting both their operations and patient care.