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QUOTED. July 9, 2018. Nele Zgavc.

Executive Summary

British Standards Institution's Nele Zgavc is concerned about the device sector's ability to deliver harmonized standards in time for compliance deadlines with the EU's new Medical Device and IVD Regulations. See what she said about it here.

"We do not know whether the deadline the [European] Commission is proposing for the adoption of these standards by the national countries is feasible." –Nele Zgavc, international lead program manager, British Standards Institution

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