Medical device unannounced audits lessons learned
European medical device regulations are undergoing many significant changes that will
impact Manufacturers, Suppliers, and Notified Bodies. The European Commission
Recommendation of 24 September 2013 (2013/473/EU) introduced the immediate requirement
for Notified Bodies to conduct unannounced audits on manufacturers of CE marked
products. As per the Commission's recommendation, the unannounced audits will occur
at least once every third year or at a higher frequency if the devices bear a high risk.
The audits could occur at the legal manufacturer's premises or one of their
critical sub-contractors or crucial suppliers.
BSI have now completed a substantial number of unannounced audits and this webinar will
focus on the BSI experience to date with the unannounced audit program highlighting the
challenges and learning points for both the Notified Body and the Manufacturers. Early
experience indicates that Manufacturers with effective quality management systems with
good control on sub-contractors, suppliers, and procedures/processes in place for
dealing with unannounced audits fared better than others.
Please note, we will cover briefly the requirements, but the focus of this webinar is on
the learning's from completed unannounced audits.