EU medtech notified bodies continue with tough act; over 1,000 certificates withdrawn in 2014
This article was originally published in SRA
Executive Summary
Last year, EU notified bodies withdrew over 1,000 certificates awarded to medical device companies for reasons including non-compliance, major non-conformities and refusal of device manufacturers to undergo an audit, according to a survey conducted by the EU association of medtech notified bodies Team-NB1,2.