Stainless Steel Alloys to Comply with EU MDR 2017/745 Updates

In 2021, EU Medical Device Regulation (2017/745) is increasing the labeling requirements on certain medical devices provided for sale within the European Union. This increased regulation is partly driven by the percentage of constituent and trace elements within the composition of the alloy materials used in medical devices. Interest is in the level of cobalt (Co) which may be present as a trace contaminant within stainless steel alloys used for medical devices. To support compliance, Carpenter Technology has updated the chemistries of popular stainless alloy options to offer variations that confirm a presence of less than 0.10 wt% of cobalt:

• 316L
• Biodur® 316LS
• 420 Modified
• Biodur® 108
• 440A
• 440C
• 430
• 416
• 410
• Custom 455®
• Custom 465®
• Custom 630 (17-4PH)
• Trim Rite®

We continue to evaluate additional stainless steel alloys on a case-by-case basis for trace elemental compositions. Contact us today for more information on our low-cobalt specific chemistry variations.