BSI implemented a routine program of unannounced visits to all our CE-certified manufacturers and, if appropriate, their critical sub-contractors and crucial suppliers. Our designating Competent Authority (MHRA) requires Notified Bodies, including BSI, to conduct unannounced audits in accordance with the recommendation. This has been a requirement of Notified Bodies since the first half of 2014.
To read the full recommendation, please download the EU Commission Recommendation of 24 September 2013.
The requirement for regular unannounced audits, found within Annex III, is the most significant change introduced by the Commission Regulation. These are in addition to the current program of compliance audits conducted by Notified Bodies. This applies to manufacturers holding EC certificates under any of the three EU Medical Devices Directives i.e. MDD, AIMD, IVD, where the legal provision for unannounced visits exists. The requirement will remain under the new Medical Device and IVD Regulations due to come into force in 2017.