C3: Classification of medical devices

15:15-15:40 Svetlana Seiter: Qualification and classification of devices under MDR and IVDR: insight into European harmonization and the national procedure in Austria

The presentation will focus on the qualification and classification of medical devices in accordance with the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) and highlight the harmonisation efforts in Europe. We will also look at the specific national procedure in Austria, covering the entire process from application submission to the final decision.

15:40-16:30 Daniel Rubisoier: Test Your Expertise: Classification of Devices under Regulation (EU) 2017/745 for medical devices

The MDR (EU) 2017/745 classifies medical devices into four risk classes: I, IIa, IIb, and III. Classification depends on the device’s intended purpose and the rules in Annex VIII. It directly affects application, documentation, conformity procedures and certification. To avoid confusion or delays, we take a closer look at what really matters in the classification process.