On September 24, 2013, the European Commission published a recommendation (2013/473/EU) on the audits and assessments performed by Notified Bodies in the field of Medical Devices. One key aspect of this recommendation concerns unannounced audits, which now have to be carried out at all manufacturers certified under one of the European Medical Device Directives (AIMDD, MDD, IVDD) at least once in three years. TÜV SÜD has now published a brochure in which the experts give answers to the 54 most important questions about unannounced audits asked by manufacturers.
While the new requirements initially caused some heated debates by both Notified Bodies and industry about the practicality of unannounced audits and the efforts they involve, first experiences since the beginning of 2014 have shown that they are well manageable by both parties.
TÜV SÜD offers comprehensive information
In a new information brochure TÜV SÜD has now collated all information that manufacturers should know in order to prepare for unannounced audits in the best possible manner. This 12-page brochure includes 54 frequently asked questions and answers on unannounced audits in general, their legal requirements, their objectives and implementation, and their frequency, start and process. Other FAQ address tests and assessments, audits at suppliers and subcontractors, unplanned events, costs, language, and logistics. The brochure is published in English and can be ordered free of charge from TÜV SÜD Product Service or downloaded as a PDF file. Our website also will include a news special that will keep readers up-to- date on all important information and new findings from the field.