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EDMA requests 5-yr transition to implement revised EU IVD framework

This article was originally published in RAJ Devices

Executive Summary

The European Commission's proposal to introduce a risk-based approach for classifying in vitro diagnostics as part of measures to overhaul the existing regulatory framework for this sector has been welcomed by IVD manufacturers even though it would require a "significant effort" on their part to adapt to the new requirements1.

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