Thursday, 15 October 2026 | 15:25 - 16:40
C2: IVDR: Regulatory deep dive, practical insights and key considerations for in-house IVD
- 15:25: Elisabeth Jaeckle & Harald Guldan: Borderline cases: When classification gets tricky
- 15:50: Andreas Oberleitner: The "Everyday Exemption”: In-House IVDs under the IVDR
- 16:15: Simone Sturm-Emerstorfer & Lukas Katacic: Navigating Class D IVDR Certification – Best Practices
Andreas Oberleitner : The “Everyday Exemption”: In-House IVDs under the IVDR
In-house IVDs are often treated as a regulatory exception, yet in practice they are a widespread and essential part of diagnostic healthcare. This talk explores the current IVDR framework and national differences, the growing importance of in-house testing, proposed changes under IVDR 2.0, and best-practice examples of how efficient and compliant implementation could look like
5 speakers
Head of Business Unit IVD
mdc medical device certification GmbH
Fachexpertin, Projektleitung / Expert, Project Management
mdc medical device certification GmbH
Regulatory Affairs and Quality Management
Ingenetix GmbH
VP Regulatory Affairs
Platomics GmbH
Quality Manager
Ingenetix GmbH