Upcoming changes to EU MDR 2017/745 next year will require devices containing more than 0.10% cobalt content to indicate the presence of cobalt as a potential carcinogenic, mutagenic, reproductive toxin substance. To address increasing regulatory scrutiny and up-classification of cobalt as a Class II RMR substance, we offer a range of stainless alloys in low-cobalt variations.
Our Medical Global Applications Engineering Lead Gaurav Lalwani and Metallurgist Raymond DeFrain, spoke with Medical Design Briefs about Biodur® 108 as a suitable alternative to cobalt chrome molybdenum for new medical devices. The material is an essentially nickel- and cobalt-free stainless alloy used in FDA-approved designs for implantable medical devices and high-strength surgical instruments. Its chemistry not only addresses the up-classification of cobalt but also provides a nickel-free option for patients with metal sensitivities and can be effectively utilized in additive manufacturing production.