FDAnews
www.fdanews.com/articles/146131-ec-guidance-for-notified-bodies-on-device-facility-inspections-expected-soon

EC Guidance for Notified Bodies on Device Facility Inspections Expected Soon

May 4, 2012
The European Commission is preparing guidance to assist notified bodies during inspections of facilities where CE-marked medical devices are made. The guidance will address issues such as product sampling, witness device testing during audits and market surveillance, according to BSI Group, a UK-based notified body. Commission officials, competent authorities and notified bodies from across the EU met in Brussels mid-April to discuss recent quality and safety concerns raised by recalls of PIP breast implants and metal-on-metal hip replacements.
International Medical Device Regulatory Monitor