Unannounced Audit

CE Marking Medical Devices - European Commission Recommendation of 24 September 2013 (2013/473/EU)

European medical device regulations are undergoing many significant changes that will impact manufacturers, suppliers, and Notified Bodies. One major and immediate change is the EU Commission requirement for Notified Bodies to conduct unannounced audits on manufacturers of CE marked products.

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 introduce unannounced audits programs in 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.

Unannounced Audit process

Manufacturers will be subject to an unannounced audit at least once every three years, and this frequency will need to be increased should the devices bear a high risk.

The Commission Recommendation states that these "unannounced audits" must be unpredictable and without prior notice, so there will be no communication with your company prior to the audit. The BSI Notified Body auditors will present themselves at your premises, and your company must provide immediate and unrestricted access.

Access to your critical sub-contractors and crucial suppliers by the Notified Body may also be required, and will be subject to identical requirements, in situations where this is likely to provide more effective control by the Notified Body. This right of access will need to be covered in your contracts with these suppliers.