BSI must implement 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) expects that Notified Bodies, including BSI, will 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 most significant change introduced by the Commission Recommendation is within Annex III, which specifies the requirement for regular "unannounced audits". These are in addition to the current program of compliance audits conducted by Notified Bodies. This change 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.