Module 17 2024

05/12/2024

Content of this Presentation

• Background; why are Unannounced Audits required? • Implementation of Unannounced Audits by Notified Bodies • Insight into the practical application of Unannounced Audits • How can Manufacturers prepare for Unannounced Audits.

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Why are unannounced audits done?

• Unannounced Audits were already possible under the Medical Device Directives (MDD); however, they were never “put into use” (see also Annex II section 5.4 and Annex V section 4.4). • On 9 February 2012, the EU Commission published an action plan based on the results of the PIP Breast Implant case investigation. One element of this plan was to carry out unannounced audits. • As a follow-up on this action plan, the EU recommendation 2013/473/EU, published on 24 September 2013, detailed the requirements for unannounced audits. • There was some debate at the time on how to enforce this recommendation, with the legality of Notified Bodies undertaking Unannounced Audit being questioned, particularly in Germany.

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