Over 1,000 certificates withdrawn as EU notified bodies toughen up
This article was originally published in Clinica
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-NB.
You may also be interested in...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-four guidance documents have been posted on the tracker since its last update.
The risk of psychiatric disorders with chloroquine and hydroxychloroquine-containing medicines received renewed attention in the EU after they were being used as potential treatments for COVID-19.
New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.