Under the EU Commission Recommendation 2013/473/EU, unannounced audits must become an established practice for medical device manufacturers as well as notified bodies. In addition to standard auditing requirements, the Recommendation requires notified bodies to visit device manufacturers and applicable critical sub-contractors and crucial suppliers at least once every three years to ensure they are fulfilling compliance requirements. Notified bodies must also demonstrate consistency with competent authorities in each EU jurisdiction. The following presentation will include new information on unannounced audits and a notified bodies experience to date, and provide attendees with a better understanding of how notified bodies are executing the recommendations and how they are communicating with each other.
- Brief review of Commission Recommendation
- Unannounced audit preparation and post-audit responsibilities
- Incorporating CAPAs into regulatory audit structure
- Updates in notified body communication and code of conduct
Sarah H. Stec, Esq., RAC
Legal and Regulatory Director
LNE/G-MED North America, Inc.