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The Future EU IVD Regulation: Practical Tips And Why The Sector Needs To Start Work Now

This article was originally published in Clinica

Executive Summary

Discussions concerning new requirements for medical devices usually seem to dominate debate on the future European Regulations, which are currently under negotiation. But it is likely to be the IVD sector that experiences the biggest upheaval when they are adopted. Amanda Maxwell spoke with Sue Spencer, head of IVDs at BSI notified body, about the practical challenges ahead for the IVD sector

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