NIPPON KINZOKU CO., LTD. commercialized ?NK-304LCO? stainless steel for injection needles in November 2020, which is compliant with the Cobalt composition regulation of the European Medical Devices Regulation (MDR), which came into effect in May 2021 and will be fully transitioned on 31 December 2028. They would like to announce that they are currently making progress in expanding sales to overseas markets.

The MDR is a regulation for marketing medical devices in Europe and is a stricter approval system than the existing Medical Device Directive (MDD). The MDR stipulates the Regulation on Classification, Labeling and Packaging of substances and mixtures (CLP), which targets the cobalt (Co) component contained in stainless steel as a carcinogen. It is less than 0.1%.

Conventional NK-304NKM stainless steel for injection needles was difficult to adapt to this regulated quantity, but in response to requests from domestic and overseas medical device manufacturers, they have succeeded in alloy design (composition adjustment) as a result of discussions with raw material manufacturers. They were able to successfully supply the material. Currently, they have started selling the amount equivalent to approximately 3% of the cobalt-regulated materials for customers using stainless steel material for injection needles.

The complete transition to MDR has been postponed from the original May 2024 to December 2028, volumes are currently increasing slightly due to the regulatory approach of individual medical manufacturers, but enquiries from the European and Chinese markets are increasing and sample shipments have already begun. The NK-304NKM has been selected as the material of choice for "thin diameter" types of needles for insulin such as "painless needles" and cosmetic applications, and is currently being used all over the world. The sales share of materials for injection needle applications is approximately 49% in Japan and 59% overseas, with an average share of approximately 55%, and quality superiority is widely recognized in the injection needle market.

In addition to maintaining a high market share, sales to the Chinese and Indian markets are expected to expand in the future due to the increasing number of diabetes patients worldwide.