Hello Amy,
The topic of alloys used in manufacture of stainless steel has been an on-going issues for many, many years and from my tangential "keeping aware" of the issues (not just for stainless steel either but for other metal/metal alloys) there has not been any specific resolution. Years ago I started reading keeping tabs on the EuroFer organisation and I found the link to a position paper they made back in 2014
https://www.eurofer.eu/publications/reference-documents/stainless-steel-issues-and-impacts-due-to-the-classification-of-nickel/. Unfortunately the General Safety and Performance Requirements (GSPR) in Annex I of the EU MDR does not help the situation with identification of carcinogenic materials. One of the comments EuroFer made was the EU does not differentiate between forms of metals thus sadly everything gets grouped in as carcinogenic. It would be nice to have more common sense used, but unfortunately because of court cases the situation worsens to the point of ridiculousness.
I am not personally aware of any discussion with Notified Bodies regarding these topics, but we have submitted a couple products with stainless steel without any untoward issues being raised during the review. However, we completed a strong argument for why extraction testing (and couple other biological evaluation tests) were not necessary and used our risk management process to support this as well. ISO 10993 series are now based on risk in regards to materials, characterisation, and testing, in order to help reduce the amount of animal testing and my own personal opinion ridiculous testing of known materials. We used the risk-based approach and as you state there is widespread use of products containing stainless steel 304, 316, or even others. I wish could provide more succinct answer, but what we have also found is a huge variation of applying requirements for the GSPR so we have had to address on an individual basis.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 20-Jun-2022 09:59
From: Amy Fowler
Subject: CMR Classification of 304 Stainless Steel
Hello Everyone,
In reviewing CMR (carcinogen, mutagen, reproductive toxin) content of materials to address EU MDR GSPRs, we have found that the common stainless steel alloy 304 contains nickel and cobalt. Both nickel and cobalt are known carcinogens per the Classification, Labelling and Packaging Regulation (EC). However, there is widespread safe use of 304 stainless steel in a wide variety of invasive and even implantable medical devices. Extraction testing is an option, but expensive.
How are other companies that use 304 stainless steel addressing this EU MDR challenge? Has anyone had a chance to discuss this issue with a Notified Body?
Thanks in advance for sharing your experience on this issue.