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European Commission formally objects to device and IVD standards

This article was originally published in RAJ Devices

Executive Summary

The European Commission has launched a formal objection to a total of 11 mandated medical device and in vitro diagnostic standards, including the risk management standard, EN ISO 14971. The commission, which is holding discussions on the issue today1, says that the standards should either be changed or that companies should not refer to them in their technical documentation.

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