Medtech Applications Relying on 8 EU Notified Bodies Subject to Audit in Australia
Friday, October 17, 2014
Lack of confidence in eight European medical device notified bodies has caused Australia's Therapeutic Goods Administration to announce that it will conduct audits of all medical device applications in the country that rely on conformity assessment reports from those notified bodies. A 2012 investigation published in BMJ questioned the business practices of the notified bodies. Although Australia has a mutual recognition agreement with EU device regulators, the TGA said it would audit those applications until further notice to ensure the quality, safety and performance standards for all medical devices on its Register of Therapeutic Goods.