Dear all,
MDR requires that "Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances."
Cobalt is widely used in medical devices alloys, as stainless steel alloys. It was recently up-classified to Carcinogenic, mutagenic and reprotoxic chemicals (CMR)1 status. S
Who knows which is the better way to label the cobalt presence? Can we use this symbol (from and ISO 7000 - 3723ISO/DIS 15223- 1:2020(E) DRAFT)
near the wording "Co"? Alternatively, which wording is more appropriated?
Thanks in advance
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antonia trevisan
Regulatory project manager /Regulatory engineer
Italy
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