Good relations with EU auditors could reduce number of surprise inspections
This article was originally published in Clinica
Executive Summary
The EU’s Notified Bodies Recommendation Group (NBRG) has issued a new draft document suggesting that notified bodies should link the frequency of unannounced audits they conduct with three driving factors. These factors include the risk classification of the devices being audited, the devices’ frequency of non-compliance and specific information that would give reason for suspicion of non-conformities of the devices or of the manufacturer’s quality management system.