How to survive unannounced audits
What was once a specter looming over medical device manufacturers has now become routine. Upon publication of the Recommendations 2013/473/EU of the EU Commission of 24 September, 2013, unannounced audits became routine for medical device manufacturers and are now firmly anchored in the Medical Device Regulation (MDR).
Most manufacturers have become accustomed to the idea that an auditor from their notified body may turn up on their doorstep at any time. They have established functioning processes which ensure the interim assessments run smoothly and efficiently. For those manufacturers who still do not feel fully confident, TÜV SÜD has compiled FAQs explaining the unannounced audit process and how to best prepare for unannounced audits. The FAQs in English are available as a downloadable PDF.