You have seen that GSPR 10.4 covers substances which are carcinogenic, mutagenic or toxic to reproduction ('CMR'), and/or having endocrine-disrupting properties, concerning their effects on the human body.
Next, look at the REACH Regulation, (EC) No 1907/2006, Article 57. It covers substances which are carcinogenic, mutagenic, toxic to reproduction, endocrine-disrupting,
persistent, bioaccumulative and/or toxic, concerning their effects on humans and/or the environment.
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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 27-Aug-2019 17:01
From: Anonymous Member
Subject: EU MDR Annex I- GSPR 10.4:Substances
This message was posted by a user wishing to remain anonymous
Hello RA folks, How do you interpret the substance requirements listed in Annex I- GSPR 10,4,1 through 10,4,4 for Active implantable devices? Is REACH compliance exempt for active implantable device regulated under AIMDD?