074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman

On this episode, I was joined by Christiana Hoffman, Executive Consultant & Business Development Manager at anteris medical GmbH. Christiana walks through:

- Article 117 requirements for Combination Products in EU

- Notified Body Opinions, Timelines, and Interactions\

-Reporting for Combination and when does Eudamed Apply

Christiana is a medical device and combination product professional within the Medtech and Pharma industry. She worked for both mid size and global manufacturers but one of the largest Notified Body TÜV SÜD, where she was responsible for Combination Products in her last role. Over the years she gained profound expertise in auditing QMS / MDD / MDR, assessing technical documentation incl. biocompatibility of a wide range of class IIa products. She is a certified auditor for ISO 13485 (TÜV SÜD) and QMB (TÜV SÜD). Christiana’s main focus and experience as SME is Article 117 MDR.  Within TÜV she was overall responsible for implementing and improving the NBOp assessment process within TÜV SÜD for the DACH & Nordics region. She is a recognized conference speaker for drug device combination products, biocompatibility and EU medical device regulation.