EU MDR Changes in Medical Device Regulatory Requirements
Changes to EU MDR 2017/745 will require devices containing more than 0.10 wt% 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 steel alloys in low-cobalt variations.
Historical data suggests that stainless steel alloys, such as the 300 and 400 families, contain between 0.05-0.40 wt% cobalt in a traditional melt, exceeding proposed EU MDR limits. With improved melting cleanliness protocols, effective scrap reuse, and recycling controls, Carpenter Technology has successfully limited the cobalt levels in several commonly used alloys, per EU MDR requirements.
Low-cobalt variants currently available for EU-MDR compliance:
- Biodur® 316LS
- 420 Modified
- Biodur® 108
- Custom 455®
- Custom 465®
- Custom 630 (17-4 PH)
- Trim Rite®
Carpenter Technology is one of the first to officially introduce low-cobalt stainless steel products to the market. The company continues to participate in public forums, including ASTM, and work closely on material standards impacted by the new regulations. Carpenter Technology is also innovating alternative materials for regulation compliance, increased quality and improved patient outcomes.
Alloys for Nickel Sensitivity and Cobalt Up-Classification
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 (CCM) 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.
Materials Matter: Advancements in Orthopedics
The landscape of the industry is changing with the new European Union Medical Device Regulations (EU MDR). OEMs and contract manufacturers have been focusing on risk mitigation, regulatory compliance, design control, and device history record. Watch our recent BoneZone webinar featuring Carpenter Technology's Brent Marini and Gaurav Lalwani with Charles Hansford from Tecomet, Gordon Hunter from Smith & Nephew and Dale Tempco, industry consultant to cover orthopedic macro trends impacting material needs. The discussion provides critical insight and practical advice on the impact of EU MDR on medical devices.