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Industry calls for fit-for-purpose definition of the role of ‘economic operators’

This article was originally published in Clinica

Executive Summary

The rules on economic operators in the proposed Medical Device Regulations have been largely aligned with the New Legislative Framework for the Marketing of Products. This framework is intended to set up common principles for all sector specific legislation in the European Union. But in so doing, some potentially confusing situations have been created for the future regulation of medical devices and IVDs which should now be resolved. Johnson & Johnson’s Céline Bourguignon* gives her views





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