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hello my name is Robin Brandt and I am an executive director of regulatory services for NSF health sciences Iamp;#39;m the author of a white paper describing how to meet new European regulatory requirements for IV DS also known as in vitro diagnostic devices as many of you know the new EU IV deregulation 746 of 2017 has replaced the IV D directive 98 79 EC manufacturers must now demonstrate compliance for the general safety and performance requirements these requirements provide broad high level criteria for safety and performance applicable to design production and post production aspects throughout the lifecycle of all IV DS manufacturers that have demonstrated compliance under the directive need to ensure that the IV D remains in conformity with the new regulation to assist NSF has developed this paper it will provide you with ideas on how you can demonstrate conformity with the safety and performance principles that are relevant to your IV D click to read the paper and perform you
