Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

EU Unannounced Audits: A Primer

This article was originally published in The Gray Sheet

Executive Summary

European device companies now undergo surprise inspections of their manufacturing processes, and there are questions firms likely have about the EU's new approach. This Q&A-format table will aid manufacturers in understanding the new unannounced audit scheme.