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Australian experience shows EU IVD transition period must not be shorter than five years

This article was originally published in SRA

Executive Summary

Experience with the implementation of new in vitro diagnostics regulations in Australia suggests that the EU is going to need a five-year transition period to ensure that all stakeholders are in a position to fully comply with anticipated new requirements1. That is the view of Jesús Rueda Rodríguez, regulatory affairs director at the European Diagnostic Manufacturers Association.

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